Clinical trial NCT05538637: Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure?
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preload-responsiveness
Keywords: preload-responsiveness
acute circulatory failure
left ventricular outflow tract velocity time integral
mitral valve velocity time integral
echocardiography
Lead sponsor: Avicenna Military Hospital
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness
timeFrame: through study completion, an average of 6 months
measure: Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marrakesh
country: Morocco
facility: Avicenna Military Hospital
state: Marrakesh Tensift El Haouz
Study officials:
affiliation: Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.
name: Younes Aissaoui, MD
role: PRINCIPAL_INVESTIGATOR
References: