AKI - Acute Kidney InjuryVRPG-AKINCT07722325
Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury
An observational study of AKI - Acute Kidney Injury, run by Sichuan Academy of Medical Sciences.
Trial summary
Acute kidney injury (AKI) is a common and serious complication in the ICU. Current diagnostic indicators (such as creatinine and urine output) exhibit significant lag, and specific hemodynamic predictive markers are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- What is being tested?
- No study intervention
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 1 May 2027
- Phase
- Observational
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
Study population: Adult ICU patients (age ≥18 years) at risk for acute kidney injury, with central venous and radial arterial catheters in place for hemodynamic monitoring, no AKI at ICU admission per KDIGO criteria, and complete data available for calculation of venous return pressure gradient (Pmsf-CVP) within 48 hours of admission.
Who may be able to join
- Age ≥18 years
- Admitted to the intensive care unit (ICU) within 48 hours
- Central venous catheter in place for continuous central venous pressure (CVP) monitoring
- Radial artery catheter in place for hemodynamic monitoring including mean systemic filling pressure (Pmsf)
- No acute kidney injury (AKI) at ICU admission according to KDIGO criteria
Who cannot join
- Maintenance hemodialysis or continuous renal replacement therapy (CRRT) prior to ICU admission
- Previous kidney transplantation
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO) support at ICU admission
- Incomplete core hemodynamic data precluding calculation of venous return pressure gradient (Pmsf-CVP) or AKI assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression
Acute kidney injury (AKI) is a common and serious complication in the ICU. Current diagnostic indicators (such as creatinine and urine output) exhibit significant lag, and specific hemodynamic predictive markers are lacking. The venous return pressure gradient (Pmsf-CVP), based on Guyton's theory, reflects the driving pressure for venous return; however, its value in the early warning of AKI remains unclear. This study aims to investigate the predictive value of the venous return pressure gradient for the onset and progression of AKI in ICU patients, and to clarify its effectiveness as an AKI risk warning indicator.
Patients admitted to the ICU within 48 hours with risk factors for AKI (including sepsis, shock, major surgery, underlying diseases, etc.) who have radial artery catheterization and can undergo hemodynamic monitoring will be enrolled. Those undergoing maintenance dialysis/CRRT, ECMO support, or with missing core data precluding calculation of Pmsf-CVP or AKI assessment will be excluded.
The venous return pressure gradient (Pmsf-CVP, mmHg) will be measured within 48 hours of ICU admission using the transient stop-flow arm arterial-venous equilibrium pressure method. The primary outcome is to evaluate the association between the venous return pressure gradient level and AKI occurrence. Secondary outcomes include correlation analyses between the venous return pressure gradient level and serum creatinine and urine output within 48 hours of ICU admission, among others.
- Conditions
- AKI - Acute Kidney Injury
- Being tested
- No study intervention
- Keywords
- Venous return pressure gradient, Acute kidney injury, Mean systemic filling pressure, Central venous pressure, Intensive care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
No study intervention. This is an observational cohort study using routine hemodynamic monitoring data (Pmsf and CVP) collected during standard clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury occurrence
Occurrence of acute kidney injury diagnosed according to KDIGO criteria (serum creatinine increase ≥1.5 times baseline, or ≥26 μmol/L within 48 hours, or urine output <0.5 mL/kg/h for ≥6 hours) during the ICU stay. The association between venous return pressure gradient (Pmsf-CVP, measured within the first 48 hours of ICU admission using the Pmsf-arm method) and AKI occurrence will be assessed by multivariable logistic regression analysis, adjusting for APACHE II score, baseline serum creatinine, lactate, mean arterial pressure, sepsis, and shock.
Measured: Within 48 hours of ICU admission
Secondary outcomes (8)
Persistent Acute Kidney Injury
Persistent AKI defined as failure of renal function to return to baseline within 48 hours after AKI occurrence during the ICU stay. The predictive value of venous return pressure gradient (Pmsf-CVP) for persistent AKI will be evaluated by ROC curve analysis.
Measured: Within 48 hours after AKI occurrence during the ICU stay
AKI severity grade
Maximum AKI stage (KDIGO stage 1, 2, or 3) achieved during the ICU stay.
Measured: At the time of maximum AKI stage during the ICU stay, up to 28 days
In-hospital mortality
All-cause mortality during the index hospitalization.
Measured: From ICU admission to hospital discharge, up to 90 days
Total length of hospital stay
Number of days from hospital admission to hospital discharge or in-hospital death, whichever comes first. Patients still hospitalized at day 90 will be censored at 90 days.
Measured: From hospital admission to discharge or death, up to 90 days
Correlation between venous return pressure gradient and serum creatinine
Spearman rank correlation analysis between Pmsf-CVP (measured within 48 hours of ICU admission) and serum creatinine levels (baseline creatinine at ICU admission and peak creatinine during ICU stay).
Measured: Within 48 hours of ICU admission
Correlation between venous return pressure gradient and lactate
Spearman rank correlation analysis between Pmsf-CVP (measured within 48 hours of ICU admission) and lactate levels obtained from the first arterial blood gas analysis within 48 hours of ICU admission.
Measured: Within 48 hours of ICU admission
Duration of mechanical ventilation
Number of days on invasive mechanical ventilation from the time of first intubation to the first successful extubation. Reintubation within 48 hours will be counted as continuous ventilation.
Measured: From intubation to first successful extubation
Length of ICU stay
Number of days from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start5 Jul 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongan Liu, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722325
- Sponsor's protocol ID
- IRB No. 321 (2026)
- Acronym
- VRPG-AKI
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eskesen TG, Wetterslev M, Perner A. Systematic review including re-analyses of 1148 individual data sets of central venous pressure as a predictor of fluid responsiveness. Intensive Care Med. 2016 Mar;42(3):324-332. doi: 10.1007/s00134-015-4168-4. Epub 2015 Dec 9.
PubMed 26650057Magder S. The use of Guyton's approach to the control of cardiac output for clinical fluid management. Ann Intensive Care. 2024 Jul 4;14(1):105. doi: 10.1186/s13613-024-01316-z.
PubMed 38963533Chen X, Wang X, Honore PM, Spapen HD, Liu D. Renal failure in critically ill patients, beware of applying (central venous) pressure on the kidney. Ann Intensive Care. 2018 Sep 20;8(1):91. doi: 10.1186/s13613-018-0439-x.
PubMed 30238174Badin J, Boulain T, Ehrmann S, Skarzynski M, Bretagnol A, Buret J, Benzekri-Lefevre D, Mercier E, Runge I, Garot D, Mathonnet A, Dequin PF, Perrotin D. Relation between mean arterial pressure and renal function in the early phase of shock: a prospective, explorative cohort study. Crit Care. 2011;15(3):R135. doi: 10.1186/cc10253. Epub 2011 Jun 6.
PubMed 21645384Wonnacott A, Meran S, Amphlett B, Talabani B, Phillips A. Epidemiology and outcomes in community-acquired versus hospital-acquired AKI. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1007-14. doi: 10.2215/CJN.07920713. Epub 2014 Mar 27.
PubMed 24677557Turgut F, Awad AS, Abdel-Rahman EM. Acute Kidney Injury: Medical Causes and Pathogenesis. J Clin Med. 2023 Jan 3;12(1):375. doi: 10.3390/jcm12010375.
PubMed 36615175Rossiter A, La A, Koyner JL, Forni LG. New biomarkers in acute kidney injury. Crit Rev Clin Lab Sci. 2024 Jan;61(1):23-44. doi: 10.1080/10408363.2023.2242481. Epub 2023 Sep 5.
PubMed 37668397Siew ED, Davenport A. The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int. 2015 Jan;87(1):46-61. doi: 10.1038/ki.2014.293. Epub 2014 Sep 17.
PubMed 25229340Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
PubMed 22113526Cerda J, Kashani K, Ostermann M, Basu RK, Bell S, Cantaluppi V, Chakaravarthi R, Costa JM, Claure-Del Granado R, Macedo E, Rhee H, Srisawat N, Wu VC, Yang L, Mehta RL. The global epidemiology of acute kidney injury: challenges and opportunities. Nat Rev Nephrol. 2026 Mar;22(3):179-198. doi: 10.1038/s41581-025-01030-4. Epub 2025 Dec 5.
PubMed 41350436Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
PubMed 24635770Chen KP, Cavender S, Lee J, Feng M, Mark RG, Celi LA, Mukamal KJ, Danziger J. Peripheral Edema, Central Venous Pressure, and Risk of AKI in Critical Illness. Clin J Am Soc Nephrol. 2016 Apr 7;11(4):602-8. doi: 10.2215/CJN.08080715. Epub 2016 Jan 19.
PubMed 26787777Goeddel LA, Hernandez M, Koffman L, Murphy Z, Khanna AK, Robich M, Whitman G, Zhou X, Bandeen-Roche K, Muschelli J 3rd, Parikh CR, Lima JAC, Crainiceanu CM, Brown C 4th, Faraday N. Fine-Mapping the Association of Acute Kidney Injury With Mean Arterial and Central Venous Pressures During Coronary Artery Bypass Surgery. Anesth Analg. 2025 Jun 1;140(6):1439-1449. doi: 10.1213/ANE.0000000000007500. Epub 2025 Apr 17.
PubMed 40244889Bolanos G F, de Pastrana SL. [Classification, diagnostic criteria and some therapeutic considerations of the solitary thyroid nodulf (author's transl)]. Rev Invest Clin. 1976 Oct-Dec;28(4):341-5. No abstract available. Spanish.
PubMed 1016436