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Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00766519
Acronym
EVOLUTION
Enrollment
104
Registered
2008-10-06
Start date
2009-02-28
Completion date
2013-04-30
Last updated
2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Surgery

Keywords

fluid responsiveness, monitoring, arterial pulse pressure

Brief 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

Detailed 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.

Interventions

OTHERvolume 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%

OTHERstandard 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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total number of patients with complicationsfirst 7 postoperative days

Secondary

MeasureTime frame
SOFA (Sequential Organ Failure Assessment) scorepostoperative days 1 and 5
Time to initial passage of flatus and fecespostoperative
duration of stay in intensive care unitpostoperative
total number of complicationsfirst 7 postoperative days
deathin-hospital and postoperative day 28
volumes of fluid administeredduration of surgery
Duration of hospital staypostoperative

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026