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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
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%
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
University Hospital
Amiens, France
University Hospital
Caen, France
Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU
Clermont-Ferrand, France
University hospital Henri-Mondor
Créteil, France
Total number of patients with complications
Time frame: first 7 postoperative days
total number of complications
Time frame: first 7 postoperative days
SOFA (Sequential Organ Failure Assessment) score
Time frame: postoperative days 1 and 5
Time to initial passage of flatus and feces
Time frame: postoperative
duration of stay in intensive care unit
Time frame: postoperative
Duration of hospital stay
Time frame: postoperative
death
Time frame: in-hospital and postoperative day 28
volumes of fluid administered
Time frame: duration of surgery
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