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

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.

Study Overview

• Status: Recruiting
• Conditions: Preload-responsiveness
• Intervention / Treatment: Diagnostic test: Echocardiography

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Younes Aissaoui, MD; Phone Number: +212661403332; Email: younes.aissaoui@live.fr

Study Locations

• Morocco
  • Marrakesh Tensift El Haouz
    • Marrakesh, Marrakesh Tensift El Haouz, Morocco, 40000
      • Recruiting
      • Avicenna Military Hospital
      • Contact: Younes Aissaoui, MD; Phone Number: +21266140333; Email: younes.aissaoui@live.fr
      • Contact: Hamza Benjakhoukh, MD; Phone Number: +212689425408; Email: h.hamza1998@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria: Acute circulatory failure.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Avicenna Military Hospital
• Investigators: Principal Investigator: Younes Aissaoui, MD, Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: echocardiography; acute circulatory failure; preload-responsiveness; left ventricular outflow tract velocity time integral; mitral valve velocity time integral
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: Mitral VTI ICU-AMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
• IPD Sharing Time Frame: After study completion for 2 years
• IPD Sharing Access Criteria: healthcare workers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No