A Phase 4 interventional study of 0.9% saline and HES 130/0.4 in Postoperative Morbidity, Postoperative Mortality and Hemostasis Change, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
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.
Fluid administration is the mainstay treatment for suspected hypovolemia during surgery, but the effects of different crystalloid and colloid solutions on outcome remain poorly explored in surgical patients.
Two recent international multicenter studies (6S and CHEST studies) have shown that, compared to crystalloid solutions, the use of hydroxyethyl starch (HES) could be responsible for higher morbidity, especially renal failure, and mortality in ICU patients, thus leading to a recent restriction of their range of indications.
In contrast, in surgical patients, recent meta-analyses have concluded on the absence of difference in terms of mortality and postoperative renal failure between crystalloids and latest generation HES. Excessive fluid administration during surgery is associated with increased risk of postoperative morbidity, including renal dysfunction and mortality. It has been suggested that, compared with the volume-restoring effects of colloids, crystalloid use may require the administration of higher fluid volumes, which may contribute to poorer outcomes. In the surgical context, clinical trials and meta-analyses have shown that individualized goal-direct fluid administration can reduce postoperative morbidity. Although most GDT studies have used colloid solutions for fluid loading, the effects of the type of fluids are currently unknown and crystalloids are proposed for first-line therapy.
Moreover conflicting results on hemostatic effects of HES have been reported. HES have been associated with increased bleeding volume and transfusion requirements, especially in the ICU setting in septic patients. Perioperative use of HES was not associated with such findings. Biological effects of HES on hemostasis has barely been investigated and only by diluting plasma of healthy donors with HES.
The proposed Haemo multicenter study will be conducted to assess if the use of HES or crystalloid solutions during an individualized GDT contribute to biological hemostatic differences in patients at moderate-to-high risk of postoperative complications after abdominal surgery. As these fluids are widely used during surgery and because of current concerns about the risks related to the use of HES-based products in ICU patients, the trial will provide important data to clinicians involved in perioperative care and hemostasis.
University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.
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Undergo elective or emergency abdominal surgery under general anesthesia
Exclusion Criteria:
Age \<18 years
individualized goal-directed fluid optimization (cardiac preload) by 250 ml boluses of 0.9% saline (up to a maximum of 30 ml/kg)
Biological: 0.9% saline
individualized goal-directed fluid optimization (cardiac preload) by 250 ml boluses of HES 130/0.4 (up to a maximum of 30 ml/kg, VOLUVEN ®, Fresenius Kabi)
Biological: HES 130/0.4
Fluid administration
Drug page: Hydroxyethyl Starch Derivatives
Fluid administration
Prothombin Time
Evaluation of hemostasis parameters
Time frame: at day 1
Activated Cephalin TimeF
Evaluation of hemostasis parameters
Time frame: at day 1
Fibrinogen level and activity
Evaluation of hemostasis parameters
Time frame: at day 1
Von Willebrand factor
Evaluation of hemostasis parameters
Time frame: at day 1
Coagulation cascade
Evaluation of hemostasis parameters
Time frame: at day 1
Thrombin Generation test
Evaluation of hemostasis parameters
Time frame: at day 1
Fibrin Clot Permeability Test
Evaluation of hemostasis parameters
Time frame: at day 1
Ran from Aug 2017 to primary completion in Jul 2018, 11 months.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxyethyl Starch Derivatives
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