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%)

NCT ID: NCT01673230

Last Updated: 2019-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Ventricular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ventricular dysfunction

cardiac surgery for ventricular dysfunction

Group Type: OTHER

cardiac surgery for ventricular dysfunction

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

patrick guinet

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Countries

France

Other Identifiers

LOC/12-01

Identifier Type: OTHER

Identifier Source: secondary_id

2012-A00364-39

Identifier Type: -

Identifier Source: org_study_id