Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

Surgery Clinical Trial

— EVOLUTION  

Official title:

Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766519
• Other study ID #: 2007-A01436-47
• Secondary ID: PHRC 2006/191520
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2008
• Last updated: November 18, 2013
• Start date: February 2009
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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 intrabdominal surgery

Description:

Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intrabdominal 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 intrabdominal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major elective intrabdominal surgery

Exclusion Criteria:

• arrhythmia

• hepatectomy

• associated thoracic surgery

• laparoscopy

• pregnancy

• allergy to colloid solution or anesthesia protocol

• arterial catheter not possible

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamic Instability
• Surgery

Intervention

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%
• 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

Locations

Country	Name	City	State
France	University Hospital	Amiens
France	University Hospital	Caen
France	Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU	Clermont-ferrand
France	University hospital Henri-Mondor	Créteil
France	University Hospital	Lille
France	University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of patients with complications		first 7 postoperative days	No
Secondary	total number of complications		first 7 postoperative days	No
Secondary	SOFA (Sequential Organ Failure Assessment) score		postoperative days 1 and 5	No
Secondary	Time to initial passage of flatus and feces		postoperative	No
Secondary	duration of stay in intensive care unit		postoperative	No
Secondary	Duration of hospital stay		postoperative	No
Secondary	death		in-hospital and postoperative day 28	No
Secondary	volumes of fluid administered		duration of surgery	Yes