Status:
COMPLETED
Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Postoperative Morbidity
Postoperative Mortality
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- • - Undergo elective or emergency abdominal surgery under general anesthesia
- With an estimated surgical duration greater than or equal to 2 hours
- With moderate-to-high risk of postoperative complications defined by an AKI risk index≥ class 3, as defined by the presence of at least 4 of the following factors: age\> 56 years, male gender, intraperitoneal surgery, active congestive heart failure, ascites, hypertension, emergency surgery, mild or moderate renal insufficiency, diabetes mellitus treated by oral or insulin therapy
- Included in Clermont-Ferrand and Montpellier centers
Exclusion
- • - Age \<18 years
- Preoperative acute heart failure
- Preoperative acute coronary insufficiency
- Preoperative severe renal failure (defined by creatinine clearance \<30 ml/min or requiring renal replacement therapy)
- Preoperative shock defined by the need for vasoactive amines
- History of allergy with the use of 6% hydroxyethyl starch 130/0.4
- Contraindication to the use of HES: sepsis, burnt patient, renal insufficiency or dialysis, cerebral hemorrhage, ICU patient , hypervolemia, lung edema, dehydration, severe hypernatremia or severe hyperchloremia, severe hepatic insufficiency, congestive heart failure, severe coagulopathy, organ transplant
- Patient's or relative's refusal to participate
- Parturient or breastfeeding woman
- Protected major (guardianship)
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03420261
Start Date
August 1 2017
End Date
July 30 2018
Last Update
February 21 2019
Active Locations (1)
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1
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003