Crystalloids or colloids for goal-directed fluid therapy with closed-loop assistance in major surgery?

Phase 1

Conditions: Major abdominal surgery, by laporotomy.
MedDRA version: 19.0Level: LLTClassification code 10065498Term: Infusion site anesthesiaSystem Organ Class: 100000004867
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-005337-31-BE

Lead Sponsor: CHU Brugmann

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.<br><br>;Secondary Objective: Study of the differences between the two groups for the following points: mortality, length of hospitalization, fluid balance, transfusion rate, incidence of hypotension, need of vasopressors and mean cardiac index. <br>Addition of a monitoring of the long term effects (at 6 months and 1 year post surgery) of both fluids (balanced cristalloids and colloids) on hepatic and renal function, occurence of pruritus and patient quality of life. ;Primary end point(s): Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2.;Timepoint(s) of evaluation of this end point: Postoperative day 2.

Secondary Outcome Measures