Status:
COMPLETED
Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery
Lead Sponsor:
Brugmann University Hospital
Conditions:
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study goal: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution. Hypothesis: Perioperative ...
Detailed Description
Controversy still persists regarding the type of fluid to use in the operating room to avoid hypovolemia and any circulatory insufficiency. While crystalloids and colloid solutions are frequently used...
Eligibility Criteria
Inclusion
- Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring a general anesthesia and a minimally invasive cardiac output monitoring (Vigileo/Flotrac)
- Patients who provide written informed consent
Exclusion
- Patients under 18 years of age
- Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
- Patients with arrhythmia and/or atrial fibrillation
- Patients who are allergic to HES
- Patients with renal insufficiency (serum creatinine of \>2 mg/ml) or hepatic dysfunction (liver enzymes \>1.5)
- Patients who has coagulation disorders (please define: values higher than 1.5x normal values
- Patients without the capacity to give written informed consent or refusal of consent
- Patients included in another protocol within a period of 3 months or Participating in another randomised trial
- Pregnancy at time of enrolment.
Key Trial Info
Start Date :
February 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2017
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02312999
Start Date
February 24 2015
End Date
December 21 2017
Last Update
January 19 2018
Active Locations (2)
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1
CHU Brugmann
Brussels, Belgium, 1020
2
Erasme
Brussels, Belgium, 1070