Crystalloid : A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgeryversus: A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgery Colloid for Intraoperative Goal-directed Fluid Therapy Using a Closed-loop System: A Randomized, Double-blinded, Controlled Trial in Major Abdominal Surgery

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Abstract

Background:

The type of fluid and volume regimen given intraoperatively both can impact patient outcome after major surgery. This two-arm, parallel, randomized controlled, double-blind, bi-center superiority study tested the hypothesis that when using closed-loop assisted goal-directed fluid therapy, balanced colloids are associated with fewer postoperative complications compared to balanced crystalloids in patients having major elective abdominal surgery.

Methods:

One hundred and sixty patients were enrolled in the protocol. All patients had maintenance-balanced crystalloid administration of 3 ml · kg–1 · h–1. A closed-loop system delivered additional 100-ml fluid boluses (patients were randomized to receive either a balanced-crystalloid or colloid solution) according to a predefined goal-directed strategy, using a stroke volume and stroke volume variation monitor. All patients were included in the analysis. The primary outcome was the Post-Operative Morbidity Survey score, a nine-domain scale, at day 2 postsurgery. Secondary outcomes included all postoperative complications.

Results:

Patients randomized in the colloid group had a lower Post-Operative Morbidity Survey score (median [interquartile range] of 2 [1 to 3] vs. 3 [1 to 4], difference –1 [95% CI, –1 to 0]; P < 0.001) and a lower incidence of postoperative complications. Total volume of fluid administered intraoperatively and net fluid balance were significantly lower in the colloid group.

Conclusions:

Under our study conditions, a colloid-based goal-directed fluid therapy was associated with fewer postoperative complications than a crystalloid one. This beneficial effect may be related to a lower intraoperative fluid balance when a balanced colloid was used. However, given the study design, the mechanism for the difference cannot be determined with certainty.

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