ALTERVOL: 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%)

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01673230

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Dysfunction	Procedure: cardiac surgery for ventricular dysfunction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Ventricular dysfunction cardiac surgery for ventricular dysfunction	Procedure: cardiac surgery for ventricular dysfunction For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).

Arm

Intervention/Treatment

Other: Ventricular dysfunction

cardiac surgery for ventricular dysfunction

Procedure: cardiac surgery for ventricular dysfunction

For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rennes University Hospital	Rennes	Brittany	France	35033

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator: patrick guinet, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT01673230

Other Study ID Numbers:

2012-A00364-39
LOC/12-01

First Posted:

Aug 27, 2012

Last Update Posted:

Dec 27, 2019

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Ventricular Dysfunction

Study Results

No Results Posted as of Dec 27, 2019