Passive Leg Raising for Predicting Fluid Responsiveness in VA-ECMO Assisted Patients

NCT04984603 | Unknown

• 1 other identifier: RECHMPL19_0616
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA ECMO) is a temporary assistance that provides a mechanical circulatory support in patients victim of cardiogenic shock (CS) or refractory cardiac arrest. During VA-ECMO support, hypotension may frequently occur due to deteriorated cardiac function, vasoplegia, or hypovolemia. Volume expansion is a common means to correct hypotension and improve systemic perfusion, but inappropriate fluid therapy is associated with adverse outcomes. As other intensive care unit (ICU) patients, VA-ECMO assisted patients have been shown to have higher mortality in case of large early fluid administration. Prediction of fluid responsiveness could achieve a lower fluid balance and improve outcomes of patients treated with VA-ECMO. Several dynamic hemodynamic parameters based on cardio-pulmonary interactions (stroke volume, pulse pressure or inferior vena cava variations induced by invasive ventilation cycles) have been described and validated for predicting fluid responsiveness in critically ill patients. Unfortunately, the VA-ECMO conditions (native cardiac circulation by-pass, low pulsatility, presence of drainage canulation in the inferior vena cava, the use of low tidal volume) make this parameters less reliable. Simulation of a fluid loading by shifting blood from the lower limbs and splanchnic compartment thanks to a revisable maneuver is another feasible approach to assess fluid responsiveness. Whereas the use of different maneuvers have been validated in the classical ICU population, very few data exist in the ECMO population and their application is questioning because blood transfer may be modified by the preload dependence of the ECMO. Recently, Luo et al showed that the variation of aortic Velocity Time Integral (VTI) measured using echocardiography induced by a Trendelenburg maneuver was predictive of fluid responsiveness during VA-ECMO support. However, their study excluded patients with low cardiac ejection (pulse pressure \< 15 mmHg) so that their data may not be extrapolated to the acute phase of heart failure requiring full mechanical support. Moreover, aortic VTI measurement suffers from low reproducibility in case of low native cardiac output (NCO) and arrythmia; and can be time-consuming. The investigators previously demonstrated in an observational prospective study that End-tidal CO2 (EtCO2) and Pulse Pressure (PP) were strongly correlated to NCO during VA-ECMO when NCO \< 2l/min. The investigators aim to study the variations of aortic VTI, EtCO2 and PP induced by Passive Leg Rising (PLR) and their ability to predict fluid responsiveness in patients under VA-ECMO.

Conditions

Cardiogenic Shock

Keywords

Adults human; Prospective study; Cardiogenic shock; Peripheral veno-arterial extracorporeal membrane oxygenation; Fluid responsiveness; Passive leg raising; Native cardiac output; End-tidal carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Correlation between VTI changes induced by PLR and VTI changes induced by fluid challenge

  VTI variations induced by PLR vs VTI variations induced by fluid challenge

  During VA-ECMO support (<28 days)

Secondary Outcomes (2)

• Correlation between EtCO2 changes induced by PLR and EtCO2 changes induced by fluid challenge

  During VA-ECMO support (<28 days)

• Correlation between PP changes induced by PLR and PP changes induced by fluid challenge

  During VA-ECMO support (<28 days)

Interventions

PLR in patients under VA-ECMO PROCEDURE

After securing the VA-ECMO tubing, PLR is realized using an automatic bed elevation technique. The lower limbs are raised to a 45° angle while the patient's trunk is lowered in supine position

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

Patients under invasive mechanical ventilation and VA-ECMO support with indication of vascular expansion

You may qualify if:

• Decision to perform volume expansion made by the attending physician for one of the following reasons:
• Hypotension or attempt to reduce vasopressor dose
• Hypoperfusion (oliguria, skin mottling, hyperlactatemia)
• Suspected Low NCO

You may not qualify if:

• Age less than 18 years
• Evidence of significant hypovolemia such as kicking drainage cannula
• Active hemorrhage
• Concomitant left ventricle assist device (Impella/ LVAD) or Intra-aortic balloon pump (IABP)
• Atrial or ventricular communication
• Significant aortic insufficiency
• Unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable VTI measurements at the left ventricular outflow tract (LVOT)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• MARC MOURAD, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 30, 2021
• Study Start: February 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

FR (1)