Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery

• Status: Completed
• Trial end date: 2017-12-21
• Target enrollment: 0
• Participant gender: All

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 fluid optimization through the use of a closed-loop assistance with a balanced starch solution (volulyte®) will be associated with a decrease in postoperative complications compared to the same approach using a balanced crystalloid solution (Plasmalyte®).

Objective: To establish which kind of intravenous fluid used for goal directed therapy with closed-loop assistance will reduce the number of postoperative complications (evaluation made by the POMS score).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brugmann University Hospital
• Treatments: Hydroxyethyl Starch Derivatives; Plasma-lyte 148

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.