Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)

Not Applicable

Completed

• Conditions: Ventricular Dysfunction
• Interventions: Procedure: cardiac surgery for ventricular dysfunction

• Registration Number: NCT01673230
• Lead Sponsor: Rennes University Hospital

Brief Summary

Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Study Start: 2012-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients >18 years old in the immediate post-operative period after cardiac surgery
• ASA 1 - 3
• Pre-operative LVEF≤45%
• Sedated with Ramsay score: 6
• Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
• With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2
• Affiliation to Health Insurance
• Consent form signed

Exclusion Criteria

• Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
• Intracardiac shunt
• Weight less than 50 kg
• History of central nervous system illness
• Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
• Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography)
• Acute kidney injury with oligoanuria
• Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more)
• Severe hypoxia (PaO2/FIO2< 100)
• Administrative control (patient under guardianship or curatorship)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ventricular dysfunction	cardiac surgery for ventricular dysfunction	cardiac surgery for ventricular dysfunction

Primary Outcome Measures

Name	Time	Method
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)	2 hours	To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.

Secondary Outcome Measures

Name	Time	Method
Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.	2 hours	Secondary objectives : * Early optimization of hemodynamics after cardiac surgery,; * To determine optimal threshold for ∆PP, ∆POP and PVI,; * To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, Brittany, France