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%)

NCT01673230 | Completed

• 2 other identifiers: 2012-A00364-39LOC/12-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.

  2 hours

Study Arms (1)

Ventricular dysfunction

OTHER

cardiac surgery for ventricular dysfunction

Procedure: cardiac surgery for ventricular dysfunction

Interventions

cardiac surgery for ventricular dysfunction 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).

Ventricular dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Conditions

Ventricular Dysfunction

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• patrick guinet

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 27, 2019

Record last verified: 2016-03

Locations

FR (1)