Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure?

NCT05538637 | Completed

• 1 other identifier: Mitral VTI ICU-AMH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preload-responsiveness

Keywords

preload-responsiveness; acute circulatory failure; left ventricular outflow tract velocity time integral; mitral valve velocity time integral; echocardiography

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 6 months

Interventions

Echocardiography DIAGNOSTIC_TEST

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.

Also known as: Mitral velocity time-integral variability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avicenna Military Hospital: lead

Study Sites (1)

Avicenna Military Hospital

Marrakesh, Marrakesh Tensift El Haouz, 40000, Morocco

Location

Related Publications (1)

• Aissaoui 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.

  PMID: 40627255 DERIVED

MeSH Terms

Conditions

Shock

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Younes Aissaoui, MD

  Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care Medicine - Head of surgical intensive care unit

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 14, 2022
• Study Start: November 6, 2022
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion for 2 years
• Access Criteria: healthcare workers

Locations

MO (1)