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%)

Ventricular Dysfunction Clinical Trial

— ALTERVOL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673230
• Other study ID #: 2012-A00364-39
• Secondary ID: LOC/12-01
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ventricular Dysfunction

Intervention

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).

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of ?PP, ?POP, PVI and Cardiac index (CI)	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.	2 hours
Secondary	Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.	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	2 hours