Preload-responsivenessNCT05538637
Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure?
An observational study of Preload-responsiveness, run by Avicenna Military Hospital at 1 site in Morocco.
Trial summary
The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preload-responsiveness
- What is being tested?
- Echocardiography
- How many people
- 50 participants
- Where
- 1 siteMorocco
- Study dates
- 6 Nov 2022to 6 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acute circulatory failure, with or without arterial hypotension. Acute circulatory failure is defined by the presence of signs of tissue hypoperfusion : prolonged capillary refil time (>5 seconds), mottling, acrocyanosis, oliguria (<0.5 mL/kg/h for more than an hour), altered mental status, lactate>2 mmol/l or metabolic acidosis (pH<7.35, base excess >-5). Arterial hypotension is defined by systolic blood pressure (SBP) < 90mmHg, mean arterial pressure (MAP) < 65 mmHg or a drop in SBP ≥ 40 mmHg. Shock is defined by the association of an acute circulatory failure and arterial hypotension.
Who may be able to join
None listed.
Who cannot join
- Recent surgery (<5 days)
- Suspected or confirmed intra-abdominal hypertension.
- Intracranial hypertension.
- Severe mitral valve disease: Severe mitral insufficiency or severe mitral stenosis
- Acute cor pulmonale
- Atrial fibrillation
- Low echogenicity
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Avicenna Military Hospital
Marrakesh, Marrakesh Tensift El Haouz, 40000
About this study
Official title: Reliability and Accuracy of Mitral Velocity Time-integral Variability With Passive Leg Raising as a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure in the ICU.
The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.
Read the detailed description
Adult patients with acute circulatory failure will be included in the study. An initial echocardiography is performed in patients placed in a semi-recumbent position. On the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (LVOT-VTI) and mitral valve (MV-VTI) velocity time integral are measured (baseline values). Then a passive leg raise test is performed and the parameters (LVOT-VTI and MV-VTI) are measured again. Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10%. In preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. Immediately after fluid therapy, the same parameters are recorded during a third echocardiography. An increase of 10% or more of LVOT-VTI , compared with baseline, defines fluid responsiveness. Patients are monitored using the standard of care practices. Hemodynamic assessment includes repetitive echocardiographic examinations if needed. In patients with shock, invasive blood pressure is monitored with an arterial catheter.
- Conditions
- Preload-responsiveness
- Being tested
- Echocardiography
- Keywords
- preload-responsiveness, acute circulatory failure, left ventricular outflow tract velocity time integral, mitral valve velocity time integral, echocardiography
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Also called Mitral velocity time-integral variability
Mitral velocity time-integral variability measurement before and after passive leg raising.
Mitral velocity time-integral variability measurement after fluid loading in preload-responsiveness patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after passive leg raising) to discriminate preload-responsive patients.
Measured: through study completion, an average of 6 months
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after fluid loading with 500 ml of saline) to discriminate fluid-responsive patients.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start6 Nov 2022
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preload-responsivenessStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Aissaoui, MD, Avicenna Military Hospital
- Investigators
- Younes Aissaoui, MD, Principal investigator, Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538637
- Sponsor's protocol ID
- Mitral VTI ICU-AMH
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Publications
Aissaoui Y, Belhadj A, Eddakya W, Bencharfa B, Bouchama A, Didi M, Elbaraka H, Fassiki N, Myatt I, Qamouss Y, Leone M, Abouqal R. Early hemodynamic phenotyping in sepsis using transthoracic echocardiography: A proof-of-concept study in a north African ICU. J Crit Care. 2026 Aug;94:155504. doi: 10.1016/j.jcrc.2026.155504. Epub 2026 Feb 26.
PubMed 41759300Aissaoui Y, Jozwiak M, Bouchama A, Bennjakhoukh H, Bencharfa B, Didi M, Abouqal R, Belhadj A. Evaluation of the mitral velocity-time integral changes induced by a passive leg raising test as a marker of fluid responsiveness in critically ill patients. J Clin Monit Comput. 2025 Dec;39(6):1159-1168. doi: 10.1007/s10877-025-01320-z. Epub 2025 Jul 8.
PubMed 40627255
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Accuracy of Mitral Velocity Time-integral Variability With Passive Leg Raising as a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure in the ICU.
- ClinicalTrials.gov ID
- NCT05538637
- Acronym / sponsor ID
- Mitral VTI ICU-AMH
- Conditions
- Preload-responsiveness
- Keywords
- preload-responsiveness, acute circulatory failure, left ventricular outflow tract velocity time integral, mitral valve velocity time integral, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Avicenna Military HospitalUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 14 Sep 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.
The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.
Detailed description
Adult patients with acute circulatory failure will be included in the study. An initial echocardiography is performed in patients placed in a semi-recumbent position. On the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (LVOT-VTI) and mitral valve (MV-VTI) velocity time integral are measured (baseline values). Then a passive leg raise test is performed and the parameters (LVOT-VTI and MV-VTI) are measured again. Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10%. In preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. Immediately after fluid therapy, the same parameters are recorded during a third echocardiography. An increase of 10% or more of LVOT-VTI , compared with baseline, defines fluid responsiveness. Patients are monitored using the standard of care practices. Hemodynamic assessment includes repetitive echocardiographic examinations if needed. In patients with shock, invasive blood pressure is monitored with an arterial catheter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute circulatory failure, with or without arterial hypotension. Acute circulatory failure is defined by the presence of signs of tissue hypoperfusion : prolonged capillary refil time (>5 seconds), mottling, acrocyanosis, oliguria (<0.5 mL/kg/h for more than an hour), altered mental status, lactate>2 mmol/l or metabolic acidosis (pH<7.35, base excess >-5). Arterial hypotension is defined by systolic blood pressure (SBP) < 90mmHg, mean arterial pressure (MAP) < 65 mmHg or a drop in SBP ≥ 40 mmHg. Shock is defined by the association of an acute circulatory failure and arterial hypotension.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Recent surgery (<5 days)
- Suspected or confirmed intra-abdominal hypertension.
- Intracranial hypertension.
- Severe mitral valve disease: Severe mitral insufficiency or severe mitral stenosis
- Acute cor pulmonale
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 |
|---|---|---|
| EchocardiographyAlso: Mitral velocity time-integral variabilityMitral velocity time-integral variability measurement before and after passive leg raising. Mitral velocity time-integral variability measurement after fluid loading in preload-responsiveness patients. | Diagnostic test | – |
Primary outcome
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness
Time frame: through study completion, an average of 6 months
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after passive leg raising) to discriminate preload-responsive patients.
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness
Time frame: through study completion, an average of 6 months
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after fluid loading with 500 ml of saline) to discriminate fluid-responsive patients.
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 7 Nov 2024.
- Derived from this study: PubMed 41759300Aissaoui Y, Belhadj A, Eddakya W, Bencharfa B, Bouchama A, Didi M, Elbaraka H, Fassiki N, Myatt I, Qamouss Y, Leone M, Abouqal R. Early hemodynamic phenotyping in sepsis using transthoracic echocardiography: A proof-of-concept study in a north African ICU. J Crit Care. 2026 Aug;94:155504. doi: 10.1016/j.jcrc.2026.155504. Epub 2026 Feb 26.
- Derived from this study: PubMed 40627255Aissaoui Y, Jozwiak M, Bouchama A, Bennjakhoukh H, Bencharfa B, Didi M, Abouqal R, Belhadj A. Evaluation of the mitral velocity-time integral changes induced by a passive leg raising test as a marker of fluid responsiveness in critically ill patients. J Clin Monit Comput. 2025 Dec;39(6):1159-1168. doi: 10.1007/s10877-025-01320-z. Epub 2025 Jul 8.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Related trials for Preload-responsiveness
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
RecruitingObservational study
Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
Critical Illness
Enrolling by invitationObservational study
Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume
To Assess the Ability of PI to Detect Preload Responsiveness
Recruiting
Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock
Fluid Responsivness, Right Ventricle
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.
Younes Aissaoui, MD principal investigator
Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.
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 Preload-responsiveness, run by Avicenna Military Hospital at 1 site in Morocco.
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 0 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 7 Nov 2024. 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 Morocco. 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?
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness (time frame: through study completion, an average of 6 months). The study lists 2 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 NCT05538637, which also lists 2 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 7 Nov 2024.