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)

This study is currently recruiting participants.

Verified March 2013 by Rennes University Hospital

Sponsor:

Information provided by (Responsible Party):

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT01673230

First received: August 22, 2012

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Purpose

Low Cardiac Output Syndrom 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	Intervention
Ventricular Dysfunction	Procedure: cardiac surgery for ventricular dysfunction

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
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), End Expiratory Occlusion Test, and Passive Leg Rising Test, Compared With Fluid Expansion.

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Mesure of ∆PP, ∆POP, PVI and Cardiac index (CI) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
To assess the sensibility and specificity of ∆PP, ∆POP, PVI, end expiratory occlusion test and passive leg rising test in comparison with 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:

Mesure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	40
Study Start Date:	September 2012

Arms	Assigned Interventions
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 end expiratory occlusion (15 seconds), passive legs rising test and fluid expansion (VOLUVEN®).

Arms

Assigned Interventions

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 end expiratory occlusion (15 seconds), passive legs rising test and fluid expansion (VOLUVEN®).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 extrasystoles, atrail fibrillation
Intracardiac shunt
Weight less than 50 kg
History of leg amputation or pelvic trauma
History of central nervous system illness
Hypersensitivity to HETASTARCH 30/0,6 (VOLUVEN®, Fresenius Kabi, Graz, Austria)
Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or trans-oesophageal echocardiography)
Acute kidney injury with oligo-anuria
Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more)
Severe hypoxia (PaO2/FIO2< 100)
HETASTARCH volume (VOLUVEN®)> 50ml/kg/24h
Administrative control (patient under guardianship or curatorship)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673230

Contacts

Contact: patrick guinet

patrick.guinet@chu-rennes.fr

Locations

France
Rennes University Hospital	Recruiting
Rennes, Brittany, France, 35033
Contact: patrick guinet patrick.guinet@chu-rennes.fr
Principal Investigator: patrick guinet

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator:

patrick guinet

Rennes University Hospital

More Information

No publications provided

Responsible Party:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT01673230 History of Changes
Other Study ID Numbers:	2012-A00364-39, LOC/12-01
Study First Received:	August 22, 2012
Last Updated:	March 13, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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