Acute Kidney Injury Due to SepsisNCT07481097
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
A study testing Hemodynamic measurements during reduction in Norepinephrine and fluid boli. in people with Acute Kidney Injury Due to Sepsis, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis
- What is being tested?
- Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (Age 18 years or older) admitted to the Intensive Care Unit.
- Primary diagnosis of Septic Shock defined according to the Third International Consensus Definitions for Sepsis (Sepsis-3): Sepsis with persisting hypotension requiring vasopressors to maintain MAP 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L despite adequate volume resuscitation.
- Patients must be mechanically ventilated and sedated to ensure baseline hemodynamic stability.
- Presence of an invasive arterial catheter and a central venous catheter.
Who cannot join
- Known pre-existing chronic kidney disease (CKD Stage 4 or 5) or patients on chronic renal replacement therapy.
- Contraindications to arm cuff inflation, including upper limb trauma, -lymphedema, arteriovenous fistula, or peripheral vascular disease.
- Severe valvular heart disease, specifically severe tricuspid regurgitation, which invalidates CVP interpretation.
- Intra-abdominal hypertension (Intra-abdominal pressure greater than 15 mmHg) which mechanically alters venous return independent of blood volume.
- Moribund patients with a predicted mortality within 24 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock: A Randomized Controlled Trial Integrating Renal Doppler Indices
The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to assess the precision and reproducibility of the non-invasive arm cuff Pmsf measurement in the septic shock population and to determine the correlation between the systemic Venous Return Gradient and the renal micro-circulatory Resistance Index (RRI).
Read the detailed description
- Sepsis-Associated Acute Kidney Injury: The Hemodynamic Paradox Sepsis-associated acute kidney injury (SA-AKI) represents a distinct pathophysiological entity characterized by macro-circulatory instability and micro-circulatory dysfunction. While historical resuscitation paradigms prioritized the restoration of Mean Arterial Pressure (MAP) to drive renal perfusion, recent evidence indicates that supra-physiological fluid administration leads to a state of fluid intolerance. The kidney is an encapsulated organ with limited compliance; therefore, elevations in Central Venous Pressure (CVP) are transmitted directly to the renal vein, increasing interstitial hydrostatic pressure. When renal interstitial pressure exceeds the pressure within the renal tubules, the net ultrafiltration gradient collapses, precipitating a decline in Glomerular Filtration Rate (GFR) independent of arterial inflow. This phenomenon, termed congestive nephropathy, suggests that the management of the venous outflow pressure is as critical as the management of arterial inflow pressure for renal preservation.
- Physiology of Venous Return: The Mean Systemic Filling Pressure Cardiac output in septic shock is rate-limited by venous return. According to the Guytonian model of circulatory physiology, venous return is governed by the upstream driving pressure, defined as Mean Systemic Filling Pressure (Pmsf), relative to the downstream back-pressure, defined as Right Atrial Pressure (RAP or CVP). Venous Return = (Pmsf - CVP) / Resistance to Venous Return Pmsf is the theoretical pressure in the systemic vasculature when cardiac flow ceases and all pressures equilibrate. It is determined by the total blood volume and the compliance of the vascular bed. Blood volume is functionally divided into unstressed volume (which fills the vessels without generating pressure) and stressed volume (which generates wall tension and Pmsf). In the early phase of septic shock, inflammatory mediators cause profound venodilation, increasing vascular capacitance and shifting blood from the stressed to the unstressed compartment, thereby reducing Pmsf and venous return. Effective resuscitation requires the manipulation of this gradient. While fluid boluses increase Pmsf, they also elevate CVP. If the CVP rises disproportionately to the Pmsf, the gradient for venous return remains unchanged or diminishes, leading to organ congestion without flow improvement. Conversely, vasopressors such as norepinephrine recruit unstressed volume into stressed volume, elevating Pmsf and the venous return gradient with minimal impact on total fluid volume.
- Why the Venous Return Gradient Approach is Superior for Renal Protection The standard hemodynamic approach often focuses on arterial inflow (MAP) while neglecting venous outflow, yet the kidney is uniquely sensitive to venous backpressure-a phenomenon termed "Congestive Nephropathy". Physiologically, renal blood flow depends on the trans-renal pressure gradient (MAP minus Renal Venous Pressure). In septic shock, while fluids may transiently improve MAP, they frequently elevate CVP (a surrogate for Renal Venous Pressure) to a greater degree, paradoxically narrowing the perfusion gradient. By guiding resuscitation based on the Venous Return Gradient (Pmsf - CVP), this protocol shifts the focus from simply "filling the tank" to "optimizing flow." This approach allows for the precise identification of patients who will benefit from vasopressors (which recruit unstressed volume to increase Pmsf without raising CVP) versus those who genuinely require volume, thereby preventing the iatrogenic renal tamponade caused by fluid overload.
- Measurement Modalities: Invasive versus Non-Invasive The clinical application of Guytonian physiology has been hindered by the difficulty of measuring Pmsf at the bedside. The reference standard involves inspiratory hold maneuvers on a mechanical ventilator to manipulate intrathoracic pressure and extrapolate the zero-flow pressure. This invasive method requires deep sedation, neuromuscular blockade, pulmonary artery catheter and controlled ventilation, limiting its utility in patients with spontaneous respiratory effort. The transient stop-flow arm arterial-venous equilibrium technique offers a non-invasive alternative. This method utilizes a pneumatic arm cuff rapidly inflated above systolic pressure to arrest brachial blood flow. As the inflow stops, the arterial and venous pressures in the distal limb equilibrate to a static pressure that correlates highly with the central Pmsf. Validation studies demonstrate that this non-invasive method has a bias of less than 1 mmHg and a percentage error of approximately 30 percent compared to invasive methods, with high intra-observer precision. This technique allows for frequent, non-invasive assessment of the fluid status without interrupting ventilation or requiring paralysis.
- Micro-Circulatory Assessment: The Renal Resistive Index Macro-hemodynamic optimization does not guarantee micro-circulatory perfusion. The Renal Resistive Index (RRI), measured via Doppler ultrasonography, provides a functional assessment of renal vascular impedance. It is calculated as (Peak Systolic Velocity - End Diastolic Velocity) / Peak Systolic Velocity. An RRI greater than 0.70 is pathologically elevated and correlates with intra-renal vasoconstriction, interstitial edema, and venous congestion. In the context of septic shock, the RRI serves as a hemodynamic stop signal. A rising RRI during fluid resuscitation indicates that the limit of renal preload reserve has been exceeded and that further fluid will result in congestive injury rather than perfusion benefit.
- Novelty of Combining Non-Invasive Pmsf with Renal Resistive Index (RRI)
This study introduces a novel "Macro-to-Micro" hemodynamic integration by coupling systemic venous return parameters with organ-specific Doppler indices. While Pmsf provides a global assessment of the potential for venous return, it does not guarantee adequate tissue perfusion at the organ level. The Renal Resistive Index (RRI) fills this gap by acting as a real-time "barometer" of renal vascular stress. Previous studies have looked at these parameters in isolation; however, combining them creates a powerful safety loop: Pmsf guides the potential for flow (the "push"), while RRI confirms the tolerance of the renal bed (the "reception"). An elevated RRI (≥0.70) in the presence of an adequate Pmsf gradient serves as an immediate "stop signal," warning that further resuscitation is causing intra-renal congestion rather than perfusion, a decision-making tool unavailable in standard protocols, making this research a multimodal renal protection study.
- Conditions
- Acute Kidney Injury Due to Sepsis
- Being tested
- Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
- Keywords
- sepsis, acute kidney injury, resuscitation, mean systemic filling pressure, renal resistive index
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic measurements during reduction in Norepinephrine and fluid boli.Other
State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume.
State 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine.
State 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard Care (Control Group) | No intervention | Patients in this group will be managed according to the Surviving Sepsis Campaign (SSC) 2021 Guidelines |
| Group B: Pmsf-Guided Resuscitation (Intervention Group). | Active comparator | The Pmsf will be measured using the transient stop-flow arm cuff method. A pneumatic tourniquet cuff is placed on the upper arm. The cuff is inflated to a pressure 50 mmHg higher than the systolic arterial pressure for a duration of 60 seconds.
The invasive arterial pressure and the ipsilateral peripheral venous pressure are recorded.
Three consecutive measurements are performed with a 5-minute interval. Measurement Technique (RRI): Renal Doppler will be performed using a convex probe. The inter-lobar arteries will be visualized, and RRI will be calculated.
Therapeutic Algorithm:
State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume.
State 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine.
State 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics Receives: Other: Hemodynamic measurements during reduction in Norepinephrine and fluid boli. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study. (AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days)
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study.
(AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days)
Measured: 7 days
Secondary outcomes (6)
Renal Resistive Index (RRI): Measured and recorded at T0 (Baseline), T24, T48, and T72 hours
Measured: 72 hours
Serum Lactate Clearance: Measured and recorded at T0, T6, T12, and T24 hours.
Measured: 24 hours
Serum Creatinine level: Measured and recorded daily for 7 days.
Measured: 7 days
Cumulative Fluid Balance: Calculated and recorded daily for 7 days.
Measured: 7 days
Vasopressor Free Days: Recorded at Day 28.
Measured: 28 days
ICU Mortality: Recorded at Day 28.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, single-center, single-blind (blinded outcome assessor), parallel-group Randomized Controlled Trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Wageh Debais, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481097
- Sponsor's protocol ID
- Mean Systemic Filling Pressure
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kellum JA, Chawla LS, Keener C, Singbartl K, Palevsky PM, Pike FL, Yealy DM, Huang DT, Angus DC; ProCESS and ProGReSS-AKI Investigators. The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock. Am J Respir Crit Care Med. 2016 Feb 1;193(3):281-7. doi: 10.1164/rccm.201505-0995OC.
PubMed 26398704Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
PubMed 24053972Higuera-Juan F, Blanco-García R. Renal Resistive Index as a Target for Hemodynamic Management in Septic Shock. Med Intensiva. 2019;43(8):499-500.
Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
PubMed 21940396Liu J, Xie H, Ye Z, Li F, Wang L. Incidence and Risk Factors of Sepsis-Associated Acute Kidney Injury: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2020;7:599.
KDIGO Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl. 2012;2:1-138.
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Rozemeijer S, de Wit N, de Grooth HJ, et al. Renal perfusion pressure and renal resistive index in patients with septic shock. Ann Intensive Care. 2019;9:126.
Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.
PubMed 20862450Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c.
PubMed 23042202Viazzi F, Leoncini G, Derchi LE, Pontremoli R. Ultrasound Doppler renal resistive index: a useful tool for the management of the hypertensive patient. J Hypertens. 2014 Jan;32(1):149-53. doi: 10.1097/HJH.0b013e328365b29c.
PubMed 24172238Le Dorze M, Bougle A, Deruddre S, Duranteau J. Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Shock. 2012 Apr;37(4):360-5. doi: 10.1097/SHK.0b013e3182467156.
PubMed 22258233Aya HD, Rhodes A, Fletcher N, Grounds RM, Cecconi M. Transient stop-flow arm arterial-venous equilibrium pressure measurement: determination of precision of the technique. J Clin Monit Comput. 2016 Feb;30(1):55-61. doi: 10.1007/s10877-015-9682-y. Epub 2015 Mar 7.
PubMed 25749976Wijnberge M, Sindhunata DP, Pinsky MR, Vlaar AP, Ouweneel E, Jansen JR, Veelo DP, Geerts BF. Estimating mean circulatory filling pressure in clinical practice: a systematic review comparing three bedside methods in the critically ill. Ann Intensive Care. 2018 Jun 20;8(1):73. doi: 10.1186/s13613-018-0418-2.
PubMed 29926230Adda I, Lai C, Teboul JL, Guerin L, Gavelli F, Monnet X. Norepinephrine potentiates the efficacy of volume expansion on mean systemic pressure in septic shock. Crit Care. 2021 Aug 21;25(1):302. doi: 10.1186/s13054-021-03711-5.
PubMed 34419120
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock: A Randomized Controlled Trial Integrating Renal Doppler Indices
- ClinicalTrials.gov ID
- NCT07481097
- Acronym / sponsor ID
- Mean Systemic Filling Pressure
- Conditions
- Acute Kidney Injury Due to Sepsis
- Keywords
- sepsis, acute kidney injury, resuscitation, mean systemic filling pressure, renal resistive index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to assess the precision and reproducibility of the non-invasive arm cuff Pmsf measurement in the septic shock population and to determine the correlation between the systemic Venous Return Gradient and the renal micro-circulatory Resistance Index (RRI).
Detailed description
- Sepsis-Associated Acute Kidney Injury: The Hemodynamic Paradox Sepsis-associated acute kidney injury (SA-AKI) represents a distinct pathophysiological entity characterized by macro-circulatory instability and micro-circulatory dysfunction. While historical resuscitation paradigms prioritized the restoration of Mean Arterial Pressure (MAP) to drive renal perfusion, recent evidence indicates that supra-physiological fluid administration leads to a state of fluid intolerance. The kidney is an encapsulated organ with limited compliance; therefore, elevations in Central Venous Pressure (CVP) are transmitted directly to the renal vein, increasing interstitial hydrostatic pressure. When renal interstitial pressure exceeds the pressure within the renal tubules, the net ultrafiltration gradient collapses, precipitating a decline in Glomerular Filtration Rate (GFR) independent of arterial inflow. This phenomenon, termed congestive nephropathy, suggests that the management of the venous outflow pressure is as critical as the management of arterial inflow pressure for renal preservation.
- Physiology of Venous Return: The Mean Systemic Filling Pressure Cardiac output in septic shock is rate-limited by venous return. According to the Guytonian model of circulatory physiology, venous return is governed by the upstream driving pressure, defined as Mean Systemic Filling Pressure (Pmsf), relative to the downstream back-pressure, defined as Right Atrial Pressure (RAP or CVP). Venous Return = (Pmsf - CVP) / Resistance to Venous Return Pmsf is the theoretical pressure in the systemic vasculature when cardiac flow ceases and all pressures equilibrate. It is determined by the total blood volume and the compliance of the vascular bed. Blood volume is functionally divided into unstressed volume (which fills the vessels without generating pressure) and stressed volume (which generates wall tension and Pmsf). In the early phase of septic shock, inflammatory mediators cause profound venodilation, increasing vascular capacitance and shifting blood from the stressed to the unstressed compartment, thereby reducing Pmsf and venous return. Effective resuscitation requires the manipulation of this gradient. While fluid boluses increase Pmsf, they also elevate CVP. If the CVP rises disproportionately to the Pmsf, the gradient for venous return remains unchanged or diminishes, leading to organ congestion without flow improvement. Conversely, vasopressors such as norepinephrine recruit unstressed volume into stressed volume, elevating Pmsf and the venous return gradient with minimal impact on total fluid volume.
- Why the Venous Return Gradient Approach is Superior for Renal Protection The standard hemodynamic approach often focuses on arterial inflow (MAP) while neglecting venous outflow, yet the kidney is uniquely sensitive to venous backpressure-a phenomenon termed "Congestive Nephropathy". Physiologically, renal blood flow depends on the trans-renal pressure gradient (MAP minus Renal Venous Pressure). In septic shock, while fluids may transiently improve MAP, they frequently elevate CVP (a surrogate for Renal Venous Pressure) to a greater degree, paradoxically narrowing the perfusion gradient. By guiding resuscitation based on the Venous Return Gradient (Pmsf - CVP), this protocol shifts the focus from simply "filling the tank" to "optimizing flow." This approach allows for the precise identification of patients who will benefit from vasopressors (which recruit unstressed volume to increase Pmsf without raising CVP) versus those who genuinely require volume, thereby preventing the iatrogenic renal tamponade caused by fluid overload.
- Measurement Modalities: Invasive versus Non-Invasive The clinical application of Guytonian physiology has been hindered by the difficulty of measuring Pmsf at the bedside. The reference standard involves inspiratory hold maneuvers on a mechanical ventilator to manipulate intrathoracic pressure and extrapolate the zero-flow pressure. This invasive method requires deep sedation, neuromuscular blockade, pulmonary artery catheter and controlled ventilation, limiting its utility in patients with spontaneous respiratory effort. The transient stop-flow arm arterial-venous equilibrium technique offers a non-invasive alternative. This method utilizes a pneumatic arm cuff rapidly inflated above systolic pressure to arrest brachial blood flow. As the inflow stops, the arterial and venous pressures in the distal limb equilibrate to a static pressure that correlates highly with the central Pmsf. Validation studies demonstrate that this non-invasive method has a bias of less than 1 mmHg and a percentage error of approximately 30 percent compared to invasive methods, with high intra-observer precision. This technique allows for frequent, non-invasive assessment of the fluid status without interrupting ventilation or requiring paralysis.
- Micro-Circulatory Assessment: The Renal Resistive Index Macro-hemodynamic optimization does not guarantee micro-circulatory perfusion. The Renal Resistive Index (RRI), measured via Doppler ultrasonography, provides a functional assessment of renal vascular impedance. It is calculated as (Peak Systolic Velocity - End Diastolic Velocity) / Peak Systolic Velocity. An RRI greater than 0.70 is pathologically elevated and correlates with intra-renal vasoconstriction, interstitial edema, and venous congestion. In the context of septic shock, the RRI serves as a hemodynamic stop signal. A rising RRI during fluid resuscitation indicates that the limit of renal preload reserve has been exceeded and that further fluid will result in congestive injury rather than perfusion benefit.
- Novelty of Combining Non-Invasive Pmsf with Renal Resistive Index (RRI)
This study introduces a novel "Macro-to-Micro" hemodynamic integration by coupling systemic venous return parameters with organ-specific Doppler indices. While Pmsf provides a global assessment of the potential for venous return, it does not guarantee adequate tissue perfusion at the organ level. The Renal Resistive Index (RRI) fills this gap by acting as a real-time "barometer" of renal vascular stress. Previous studies have looked at these parameters in isolation; however, combining them creates a powerful safety loop: Pmsf guides the potential for flow (the "push"), while RRI confirms the tolerance of the renal bed (the "reception"). An elevated RRI (≥0.70) in the presence of an adequate Pmsf gradient serves as an immediate "stop signal," warning that further resuscitation is causing intra-renal congestion rather than perfusion, a decision-making tool unavailable in standard protocols, making this research a multimodal renal protection study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective, single-center, single-blind (blinded outcome assessor), parallel-group Randomized Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard Care (Control Group) | No intervention | –Patients in this group will be managed according to the Surviving Sepsis Campaign (SSC) 2021 Guidelines |
| Group B: Pmsf-Guided Resuscitation (Intervention Group). | Active comparator | Other: Hemodynamic measurements during reduction in Norepinephrine and fluid boli.The Pmsf will be measured using the transient stop-flow arm cuff method. A pneumatic tourniquet cuff is placed on the upper arm. The cuff is inflated to a pressure 50 mmHg higher than the systolic arterial pressure for a duration of 60 seconds. The invasive arterial pressure and the ipsilateral peripheral venous pressure are recorded. Three consecutive measurements are performed with a 5-minute interval. Measurement Technique (RRI): Renal Doppler will be performed using a convex probe. The inter-lobar arteries will be visualized, and RRI will be calculated. Therapeutic Algorithm: State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume. State 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine. State 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (Age 18 years or older) admitted to the Intensive Care Unit.
- Primary diagnosis of Septic Shock defined according to the Third International Consensus Definitions for Sepsis (Sepsis-3): Sepsis with persisting hypotension requiring vasopressors to maintain MAP 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L despite adequate volume resuscitation.
- Patients must be mechanically ventilated and sedated to ensure baseline hemodynamic stability.
- Presence of an invasive arterial catheter and a central venous catheter.
Key exclusion criteria (5 listed)
- Known pre-existing chronic kidney disease (CKD Stage 4 or 5) or patients on chronic renal replacement therapy.
- Contraindications to arm cuff inflation, including upper limb trauma, -lymphedema, arteriovenous fistula, or peripheral vascular disease.
- Severe valvular heart disease, specifically severe tricuspid regurgitation, which invalidates CVP interpretation.
- Intra-abdominal hypertension (Intra-abdominal pressure greater than 15 mmHg) which mechanically alters venous return independent of blood volume.
- Moribund patients with a predicted mortality within 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic measurements during reduction in Norepinephrine and fluid boli.State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume. State 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine. State 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics | Other | Group B: Pmsf-Guided Resuscitation (Intervention Group). |
Primary outcome
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study. (AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days)
Time frame: 7 days
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study. (AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days)
6 secondary outcomes
Renal Resistive Index (RRI): Measured and recorded at T0 (Baseline), T24, T48, and T72 hours
Time frame: 72 hours
Serum Lactate Clearance: Measured and recorded at T0, T6, T12, and T24 hours.
Time frame: 24 hours
Serum Creatinine level: Measured and recorded daily for 7 days.
Time frame: 7 days
Cumulative Fluid Balance: Calculated and recorded daily for 7 days.
Time frame: 7 days
Vasopressor Free Days: Recorded at Day 28.
Time frame: 28 days
ICU Mortality: Recorded at Day 28.
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 26398704Kellum JA, Chawla LS, Keener C, Singbartl K, Palevsky PM, Pike FL, Yealy DM, Huang DT, Angus DC; ProCESS and ProGReSS-AKI Investigators. The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock. Am J Respir Crit Care Med. 2016 Feb 1;193(3):281-7. doi: 10.1164/rccm.201505-0995OC.
- Background: PubMed 24053972Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
- BackgroundHiguera-Juan F, Blanco-García R. Renal Resistive Index as a Target for Hemodynamic Management in Septic Shock. Med Intensiva. 2019;43(8):499-500.
- Background: PubMed 21940396Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
- BackgroundLiu J, Xie H, Ye Z, Li F, Wang L. Incidence and Risk Factors of Sepsis-Associated Acute Kidney Injury: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2020;7:599.
- BackgroundKDIGO Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl. 2012;2:1-138.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- BackgroundRozemeijer S, de Wit N, de Grooth HJ, et al. Renal perfusion pressure and renal resistive index in patients with septic shock. Ann Intensive Care. 2019;9:126.
- Background: PubMed 20862450Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.
- Background: PubMed 23042202Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c.
- Background: PubMed 24172238Viazzi F, Leoncini G, Derchi LE, Pontremoli R. Ultrasound Doppler renal resistive index: a useful tool for the management of the hypertensive patient. J Hypertens. 2014 Jan;32(1):149-53. doi: 10.1097/HJH.0b013e328365b29c.
- Background: PubMed 22258233Le Dorze M, Bougle A, Deruddre S, Duranteau J. Renal Doppler ultrasound: a new tool to assess renal perfusion in critical illness. Shock. 2012 Apr;37(4):360-5. doi: 10.1097/SHK.0b013e3182467156.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis, Acute Kidney Injury Due to Sepsis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
RecruitingObservational study
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane
Acute Kidney Injury Due to Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic measurements during reduction in Norepinephrine and fluid boli. in people with Acute Kidney Injury Due to Sepsis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Wageh Debais, assistant lecturer (+201032090320, markwageh@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study. (AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481097, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.