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Completed

NCT Number: NCT00766519

Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume optimization

Other

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%

Other names: preload optimization

standard volume administration

Other

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

Other names: fluid compensation

Primary outcomes

  1. Total number of patients with complications

    Time frame: first 7 postoperative days

Secondary outcomes

  1. total number of complications

    Time frame: first 7 postoperative days

  2. SOFA (Sequential Organ Failure Assessment) score

    Time frame: postoperative days 1 and 5

  3. Time to initial passage of flatus and feces

    Time frame: postoperative

  4. duration of stay in intensive care unit

    Time frame: postoperative

  5. Duration of hospital stay

    Time frame: postoperative

  6. death

    Time frame: in-hospital and postoperative day 28

  7. volumes of fluid administered

    Time frame: duration of surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: EVOLUTION

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2008
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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