drugset / Trial / NCT03420261

Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study)

NCT03420261

Phase 4 Completed 56 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery. Further investigation include the analysis of hemostasis modifications according to the fluid group during the first 7 days after abdominal surgery.

Timeline

Start
2017-08-01
Primary completion
2018-07-22
Completion
2018-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Volulyte Other / unclassified 250 ml
Comparator sodium chloride Unknown 250 ml

Indications

No indication recorded.