Cardiogenic ShockNCT05271227
Volume Responsiveness By Ultrasound Of Carotid Blood Flow In Patients With Cardiogenic Shock
An observational study of Cardiogenic Shock and Volume Responsiveness, run by Alexandria University at 1 site in Egypt.
Trial summary
Resuscitation of critically ill patients has changed since the advent of goal directed therapy. Today, practitioners providing fluid resuscitation are attentive of the danger associated with volume depletion while being aware of the morbidity of volume overload. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock, Volume Responsiveness, Ultrasound
- What is being tested?
- Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test.
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2020to 20 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 cardiogenic shock patients of both gender admitted to intensive critical care units. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine. An informed consent was taken from the patients' next of kin before their enrollment in the study.
Who may be able to join
- Age > 18 Y.
- Cardiogenic shock.
Who cannot join
- Age < 18 Y.
- Pregnant females.
- All types of shock state other than cardiogenic.
- Peripheral arterial disease.
- Non consenting patients.
- Unable to tolerate passive leg raise (PLR).
- Common carotid artery stenosis greater than 50 % (systolic peak velocity >182 cm/s and/or diastolic velocity >30 cm/s by Doppler ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Volume Responsiveness By Ultrasound Parameters Of Carotid Blood Flow In Patients With Cardiogenic Shock
Resuscitation of critically ill patients has changed since the advent of goal directed therapy. Today, practitioners providing fluid resuscitation are attentive of the danger associated with volume depletion while being aware of the morbidity of volume overload. Fluid resuscitation must be rapid, precise, and individually tailored to each patient based on reliable data obtained by various means inside ICU setting.
There is no non-invasive method that can reliably and accurately identify fluid responsiveness. As such, in patients with undifferentiated shock, treatment often involves empiric fluid administration, in the hopes that volume expansion will increase preload, which will then serve to increase cardiac output (CO). However, for patients on the flat portion of the Starling curve, aggressive fluid administration results in no appreciable increase in CO and may be detrimental to hemodynamically unstable patients.
Read the detailed description
Study location and population: Alexandria Main University Hospitals ICU, Alexandria Egypt. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine was obtained before the start of the study. Sample size was estimated using PASS version 20 program. The minimal hypothesized total sample size of 40 cardiogenic shock patients of both sexes is needed to determine the sensitivity and specificity of cardiac output measurement using either bedside ultrasound on carotid artery and TTE (Standard) while assessing volume responsiveness with 95 % confidence level and 80 % power using z-test.
Study procedures: All enrolled patients were subjected on admission to thorough history taking including age, sex, date of ICU admission and preexisting underlying disease (Diabetes Mellitus, hypertension), presence of sepsis, smoking, analgesic abuse. Full clinical examination. Severity of illness was assessed by Acute Physiological And Chronic Health Evaluation-ΙΙ (APACHE ΙΙ). ICU length of stay (LOS) and final outcome were recorded.
Noninvasive measurement of Systolic arterial pressure, diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), and temperature were recorded upon admission and after PLR.
Fluid challenge: A PLR was performed, Transferring a patient to the passive leg raising (PLR) position (in which the lower limbs are elevated at 45_ while the trunk is lying supine) transfers venous blood from the legs to the intrathoracic compartment and increases cardiac preload around 300-500 mL.
Carotid ultrasonography and Echocardiogram: Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume. Multiplying the stroke volume by the heart rate yields the cardiac output, typically reported in liters per minute.
Stroke volume can be estimated by using a combination of 2D and Doppler imaging. HR was recorded before and after PLR test then CO is calculated by equation of:
CO = π × (LVOTd)2/4 × VTI LVOT × HR Percent change is [(cardiac output after passive leg raising - cardiac output before passive leg raising)/cardiac output after passive leg raising] × 100%. A greater than 10% increase in cardiac output would predict volume responsiveness and constitute an indication for a 500-mL fluid bolus. Measurements were repeated as needed, and fluid resuscitation continued until no further response to passive leg raising was noted.
Changes (%) =100 X (post-FC value - baseline value)/ baseline value
Patients were divided into 2 groups:
Responder is defined by an increase of 10% or more. Non responder is less than 10%. The Common Carotid artery is a large superficial accessible artery so carotid doppler flow imaging would be simple, non-invasive method to assess volume responsiveness. Use of Velocity Time Integral of flow through the Common Carotid artery (Carotid VTI) and Passive Leg Raising (PLR) described as a marker of volume responsiveness in hemodynamically unstable patients.
Carotid flow is measured during the passive leg raising maneuver by using a linear array transducer positioned in the long axis over the CCA, after procuring a longitudinal view of the common carotid artery, pulsed Doppler analysis at 2 cm from the bifurcation was performed. The CCA diameter is measured from opposing points of the vessel's intimal wall, with the velocity time integral determined automatically using spectral Doppler envelopes and the sample obtained from the center of the artery. Common carotid artery blood flow per minute is calculated by the equation CBF= π × (CCA diameter)2/4 × CCA velocity time integral × heart rate This parameter is measured both before and after the passive leg raising to determine the percent change in CCA blood flow. An increase in CCA flow with passive leg raising only occurs in patients with shock, and an increase of greater than 20% is highly predictive of volume responsiveness.
HR is recorded before and after PLR then CBF was calculated by the following equation:
CBF = π × (CCA diameter)2/4 × VTI CCA × HR
Patients was divided into 2 groups:
Responder is defined by an increase of 20% or more. Non responder is less than 20%. After fluid challenge we remeasured Systolic arterial pressure, diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) to assess clinical response to the fluid challenge.
- Conditions
- Cardiogenic Shock, Volume Responsiveness, Ultrasound
- Being tested
- Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test.
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test.Other
VTI-LVOT was measured by echo by placing the pulsed wave Doppler sample gate in the LVOT diameter in apical-5-chamber window. VTI-LVOT was obtained by manually tracing the Doppler velocity spectrum. LVOT velocity time integral was recorded before and after PLR test within 2 minutes. Carotid blood flow was measured by using two-dimensional image, the optimal image of the long-axis view was obtained at the common carotid artery. The sample volume was placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination,The angle correction cursor was placed parallel to the direction of blood flow. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°).
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic Shock Patients | Cardiac output and Carotid Blood flow is measured before \& after PLR test, then percent change is calculated were increase in cardiac output with 10 % or more is considered volume responder.
Measurements can be repeated as needed, and fluid resuscitation continues until no further response to passive leg raising is noted. Receives: Other: Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Carotid Blood Flow after PLR test.
The common carotid artery will be scanned in transverse and longitudinal planes. Spectral Doppler tracings will be then obtained by placing a 0.5 mm sample gate through the center of vessel, within 2-3 cm proximal to the carotid bulb in the longitudinal plane, in accordance to standard guidelines. The angle correction cursor will be placed parallel to the direction of blood flow. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is [(cardiac output after passive leg raising - carotid blood flow before passive leg raising)/carotid blood flow after passive leg raising] × 100%. A greater than 20% increase in carotid blood flow would predict volume responsiveness.
Measured: Change in carotid blood flow within 2 minutes after PLR.
Percent Change in Cardiac Output after PLR test.
Cardiac output is measured using pulsed Doppler imaging where phase-array transducer positioned just proximal to the aortic valve. The velocity time integral is measured by tracing the modal velocity then stroke volume is calculated.CO is SV multiplied by HR. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is [(cardiac output after passive leg raising - cardiac output before passive leg raising)/cardiac output after passive leg raising] × 100%. A greater than 10% increase in cardiac output would predict volume responsiveness.
Measured: Change in cardiac output within 2 minutes after PLR.
Blood Pressure before and after PLR test.
Measure Blood Pressure and record reading in mmHg before and after PLR test.
Measured: Change in blood pressure 1 minute after PLR.
Heart rate before and after PLR test.
Record Heart Rate readings on monitor in BPM (beat per minute) before and after PLR test.
Measured: Change in heart rate 1 minute after PLR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start25 Mar 2020
- Primary completion20 Feb 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Yousri, Alexandria University
- Investigators
- Ahmed M ElMenshawy, Lecturer, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271227
- Sponsor's protocol ID
- VR by CBF in CS patients
- Status last verified
- Mar 2022
- First submitted
- 23 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sadaka F, Juarez M, Naydenov S, O'Brien J. Fluid resuscitation in septic shock: the effect of increasing fluid balance on mortality. J Intensive Care Med. 2014 Jul-Aug;29(4):213-7. doi: 10.1177/0885066613478899. Epub 2013 Feb 27.
PubMed 23753235Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.
PubMed 18628220Evans D, Ferraioli G, Snellings J, Levitov A. Volume responsiveness in critically ill patients: use of sonography to guide management. J Ultrasound Med. 2014 Jan;33(1):3-7. doi: 10.7863/ultra.33.1.3. No abstract available.
PubMed 24371093Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
PubMed 18214429Ma IWY, Caplin JD, Azad A, Wilson C, Fifer MA, Bagchi A, Liteplo AS, Noble VE. Correlation of carotid blood flow and corrected carotid flow time with invasive cardiac output measurements. Crit Ultrasound J. 2017 Dec;9(1):10. doi: 10.1186/s13089-017-0065-0. Epub 2017 Apr 20.
PubMed 28429291Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PubMed 16540963
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Volume Responsiveness By Ultrasound Parameters Of Carotid Blood Flow In Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT05271227
- Acronym / sponsor ID
- VR by CBF in CS patients
- Conditions
- Cardiogenic Shock, Volume Responsiveness, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 8 Mar 2022 (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.
Resuscitation of critically ill patients has changed since the advent of goal directed therapy. Today, practitioners providing fluid resuscitation are attentive of the danger associated with volume depletion while being aware of the morbidity of volume overload. Fluid resuscitation must be rapid, precise, and individually tailored to each patient based on reliable data obtained by various means inside ICU setting.
There is no non-invasive method that can reliably and accurately identify fluid responsiveness. As such, in patients with undifferentiated shock, treatment often involves empiric fluid administration, in the hopes that volume expansion will increase preload, which will then serve to increase cardiac output (CO). However, for patients on the flat portion of the Starling curve, aggressive fluid administration results in no appreciable increase in CO and may be detrimental to hemodynamically unstable patients.
Detailed description
Study location and population: Alexandria Main University Hospitals ICU, Alexandria Egypt. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine was obtained before the start of the study. Sample size was estimated using PASS version 20 program. The minimal hypothesized total sample size of 40 cardiogenic shock patients of both sexes is needed to determine the sensitivity and specificity of cardiac output measurement using either bedside ultrasound on carotid artery and TTE (Standard) while assessing volume responsiveness with 95 % confidence level and 80 % power using z-test.
Study procedures: All enrolled patients were subjected on admission to thorough history taking including age, sex, date of ICU admission and preexisting underlying disease (Diabetes Mellitus, hypertension), presence of sepsis, smoking, analgesic abuse. Full clinical examination. Severity of illness was assessed by Acute Physiological And Chronic Health Evaluation-ΙΙ (APACHE ΙΙ). ICU length of stay (LOS) and final outcome were recorded.
Noninvasive measurement of Systolic arterial pressure, diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), and temperature were recorded upon admission and after PLR.
Fluid challenge: A PLR was performed, Transferring a patient to the passive leg raising (PLR) position (in which the lower limbs are elevated at 45_ while the trunk is lying supine) transfers venous blood from the legs to the intrathoracic compartment and increases cardiac preload around 300-500 mL.
Carotid ultrasonography and Echocardiogram: Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume. Multiplying the stroke volume by the heart rate yields the cardiac output, typically reported in liters per minute.
Stroke volume can be estimated by using a combination of 2D and Doppler imaging. HR was recorded before and after PLR test then CO is calculated by equation of:
CO = π × (LVOTd)2/4 × VTI LVOT × HR Percent change is [(cardiac output after passive leg raising - cardiac output before passive leg raising)/cardiac output after passive leg raising] × 100%. A greater than 10% increase in cardiac output would predict volume responsiveness and constitute an indication for a 500-mL fluid bolus. Measurements were repeated as needed, and fluid resuscitation continued until no further response to passive leg raising was noted.
Changes (%) =100 X (post-FC value - baseline value)/ baseline value
Patients were divided into 2 groups:
Responder is defined by an increase of 10% or more. Non responder is less than 10%. The Common Carotid artery is a large superficial accessible artery so carotid doppler flow imaging would be simple, non-invasive method to assess volume responsiveness. Use of Velocity Time Integral of flow through the Common Carotid artery (Carotid VTI) and Passive Leg Raising (PLR) described as a marker of volume responsiveness in hemodynamically unstable patients.
Carotid flow is measured during the passive leg raising maneuver by using a linear array transducer positioned in the long axis over the CCA, after procuring a longitudinal view of the common carotid artery, pulsed Doppler analysis at 2 cm from the bifurcation was performed. The CCA diameter is measured from opposing points of the vessel's intimal wall, with the velocity time integral determined automatically using spectral Doppler envelopes and the sample obtained from the center of the artery. Common carotid artery blood flow per minute is calculated by the equation CBF= π × (CCA diameter)2/4 × CCA velocity time integral × heart rate This parameter is measured both before and after the passive leg raising to determine the percent change in CCA blood flow. An increase in CCA flow with passive leg raising only occurs in patients with shock, and an increase of greater than 20% is highly predictive of volume responsiveness.
HR is recorded before and after PLR then CBF was calculated by the following equation:
CBF = π × (CCA diameter)2/4 × VTI CCA × HR
Patients was divided into 2 groups:
Responder is defined by an increase of 20% or more. Non responder is less than 20%. After fluid challenge we remeasured Systolic arterial pressure, diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) to assess clinical response to the fluid challenge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic Shock Patients | – | Other: Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test.Cardiac output and Carotid Blood flow is measured before \& after PLR test, then percent change is calculated were increase in cardiac output with 10 % or more is considered volume responder. Measurements can be repeated as needed, and fluid resuscitation continues until no further response to passive leg raising is noted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 cardiogenic shock patients of both gender admitted to intensive critical care units. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine. An informed consent was taken from the patients' next of kin before their enrollment in the study.
Key inclusion criteria (2 listed)
- Age > 18 Y.
- Cardiogenic shock.
Key exclusion criteria (7 listed)
- Age < 18 Y.
- Pregnant females.
- All types of shock state other than cardiogenic.
- Peripheral arterial disease.
- Non consenting patients.
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 |
|---|---|---|
| Transthoracic echocardiography and Carotid artery doppler (PHILIPS HD11 XE ultrasound device) before and after PLR test.VTI-LVOT was measured by echo by placing the pulsed wave Doppler sample gate in the LVOT diameter in apical-5-chamber window. VTI-LVOT was obtained by manually tracing the Doppler velocity spectrum. LVOT velocity time integral was recorded before and after PLR test within 2 minutes. Carotid blood flow was measured by using two-dimensional image, the optimal image of the long-axis view was obtained at the common carotid artery. The sample volume was placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination,The angle correction cursor was placed parallel to the direction of blood flow. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). | Other | Cardiogenic Shock Patients |
Primary outcome
Percent Change in Carotid Blood Flow after PLR test.
Time frame: Change in carotid blood flow within 2 minutes after PLR.
The common carotid artery will be scanned in transverse and longitudinal planes. Spectral Doppler tracings will be then obtained by placing a 0.5 mm sample gate through the center of vessel, within 2-3 cm proximal to the carotid bulb in the longitudinal plane, in accordance to standard guidelines. The angle correction cursor will be placed parallel to the direction of blood flow. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is [(cardiac output after passive leg raising - carotid blood flow before passive leg raising)/carotid blood flow after passive leg raising] × 100%. A greater than 20% increase in carotid blood flow would predict volume responsiveness.
Percent Change in Cardiac Output after PLR test.
Time frame: Change in cardiac output within 2 minutes after PLR.
Cardiac output is measured using pulsed Doppler imaging where phase-array transducer positioned just proximal to the aortic valve. The velocity time integral is measured by tracing the modal velocity then stroke volume is calculated.CO is SV multiplied by HR. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is [(cardiac output after passive leg raising - cardiac output before passive leg raising)/cardiac output after passive leg raising] × 100%. A greater than 10% increase in cardiac output would predict volume responsiveness.
Blood Pressure before and after PLR test.
Time frame: Change in blood pressure 1 minute after PLR.
Measure Blood Pressure and record reading in mmHg before and after PLR test.
Heart rate before and after PLR test.
Time frame: Change in heart rate 1 minute after PLR.
Record Heart Rate readings on monitor in BPM (beat per minute) before and after PLR test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 23753235Sadaka F, Juarez M, Naydenov S, O'Brien J. Fluid resuscitation in septic shock: the effect of increasing fluid balance on mortality. J Intensive Care Med. 2014 Jul-Aug;29(4):213-7. doi: 10.1177/0885066613478899. Epub 2013 Feb 27.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Background: PubMed 18628220Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.
- Background: PubMed 24371093Evans D, Ferraioli G, Snellings J, Levitov A. Volume responsiveness in critically ill patients: use of sonography to guide management. J Ultrasound Med. 2014 Jan;33(1):3-7. doi: 10.7863/ultra.33.1.3. No abstract available.
- Background: PubMed 18214429Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
- Background: PubMed 28429291Ma IWY, Caplin JD, Azad A, Wilson C, Fifer MA, Bagchi A, Liteplo AS, Noble VE. Correlation of carotid blood flow and corrected carotid flow time with invasive cardiac output measurements. Crit Ultrasound J. 2017 Dec;9(1):10. doi: 10.1186/s13089-017-0065-0. Epub 2017 Apr 20.
- Background: PubMed 16540963Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
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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. This study is not recruiting at the moment.
Ahmed M ElMenshawy, Lecturer study director
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Volume Responsiveness, run by Alexandria 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 8 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Carotid Blood Flow after PLR test. (time frame: Change in carotid blood flow within 2 minutes after PLR.). The study lists 4 primary outcomes in all. 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 NCT05271227, which also lists 7 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 8 Mar 2022.