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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%) (ALTERVOL)

Primary Purpose

Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac surgery for ventricular dysfunction
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventricular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ventricular dysfunction

Arm Description

cardiac surgery for ventricular dysfunction

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2012
Last Updated
December 26, 2019
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01673230
Brief 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%)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventricular dysfunction
Arm Type
Other
Arm Description
cardiac surgery for ventricular dysfunction
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery for ventricular dysfunction
Intervention Description
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).
Primary Outcome Measure Information:
Title
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.
Description
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
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
patrick guinet
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Learn more about this trial

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%)

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