Effect of Intraoperative Volume Optimization on Outcome After Intraabdominal Surgery - Full Text View

Sponsored by:	University Hospital, Lille
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00766519

Purpose

The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intraabdominal surgery

Condition	Intervention	Phase
Fluid Therapy Surgery	Other: volume optimization Other: standard volume administration	Phase IV

Drug Information available for: Starch Hetastarch Ringer's lactate Ringer's solution

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Effect of Intraoperative Volume Optimization on Outcome After Intraabdominal Surgery: a Multicenter, Randomized, Double-Blind, Comparative Study

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:

Total number of patients with complications [ Time Frame: first 7 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

total number of complications [ Time Frame: first 7 postoperative days ] [ Designated as safety issue: No ]
SOFA (Sequential Organ Failure Assessment) score [ Time Frame: postoperative days 1 and 5 ] [ Designated as safety issue: No ]
Time to initial passage of flatus and feces [ Time Frame: postoperative ] [ Designated as safety issue: No ]
duration of stay in intensive care unit [ Time Frame: postoperative ] [ Designated as safety issue: No ]
Duration of hospital stay [ Time Frame: postoperative ] [ Designated as safety issue: No ]
death [ Time Frame: in-hospital and postoperative day 28 ] [ Designated as safety issue: No ]
volumes of fluid administered [ Time Frame: duration of surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading	Other: volume optimization Fluid management: basal fluid administration = 5 ml/kg/h lactated Ringer's solution + systematic minimization of the arterial pulse pressure variation (PPV) to 10% or less by volume loading (6% hydroxyethyl starch) throughout surgery hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) only if PPV is > 10%
2: Active Comparator Fluid administration according to standard recommendations	Other: standard volume administration Fluid management: basal fluid administration = 5 ml/kg/h lactated Ringer's solution hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) according to predetermined algorithm primarily based on mean arterial pressure, heart rate, and urine output, and secondary on PPV

Detailed Description:

Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intraabdominal surgery. In these studies, however, the number of patients was often small, and management in control groups as well as postoperative complications were usually not precisely defined. In addition, widespread use of oesophageal doppler cannot be advocated in routine surgery, and the strategy necessitates repeated volume loading. This may lead to unnecessary intravenous fluids which may be deleterious, and intraoperative fluid restriction has also been shown to improve clinical outcome. In this context, indices reflecting the hemodynamic changes during mechanical ventilation (the so-called "dynamic indices", and more specifically the respiratory-induced pulse pressure variation) have been shown to accurately predict fluid responsiveness in mechanically ventilated patients. Automated and continuous calculation of pulse pressure variation variation from standard peripheral (typically radial) arterial line has recently been validated. This study was thus designed to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on pulse pressure variation monitoring would improve outcome after intraabdominal surgery.

Eligibility

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

Criteria

Inclusion Criteria:

major elective intraabdominal surgery

Exclusion Criteria:

arrhythmia
hepatectomy
associated thoracic surgery
laparoscopy
pregnancy
allergy to colloid solution or anesthesia protocol
arterial catheter not possible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766519

Contacts

Contact: Benoit TAVERNIER, MD, PhD	(33) 320 44 40 74	btavernier@chru-lille.fr
Contact: Aurelie GOZDZIASZEK, RA	(33) 320 44 41 45 ext 35726	a-gozdziaszek@chru-lille.fr

Locations

France
University Hospital
Lille, France, 59000
University Hospital
Amiens, France, 80054
University Hospital
Rouen, France, 76031
University hospital Henri-Mondor
Créteil, France, 94010
University Hospital Bicêtre
Le Kremlin Bicêtre, France, 94275
University Hospital
Reims, France, 51092
University Hospital
Caen, France, 14033

Sponsors and Collaborators

University Hospital, Lille

Investigators

Study Director:	Benoit TAVERNIER, MD, PhD	University Hospital, Lille
Principal Investigator:	Benoit VALLET, MD, PhD	University Hospital, Lille

More Information

Responsible Party:	Fédération d'anesthésie-réanimation, University Hospital, Lille (France) ( Benoit TAVERNIER, M.D., Ph.D. )
Study ID Numbers:	2007-A01436-47, CPP 08/11 - PHRC 2006/1915
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766519
Health Authority:	France: Ministry of Health; France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Lille:

fluid responsiveness
monitoring
arterial pulse pressure

Study placed in the following topic categories:

Hetastarch

ClinicalTrials.gov processed this record on January 16, 2009