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

NCT02312999 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-01-19

No results posted yet for this study

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).

Conditions

  • Surgery

Interventions

DRUG

Plasmalyte

DRUG

Volulyte

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Amélie Delaporte, MD · CHU Brugmann

  • Alexandre Joosten, MD · Erasme

  • Philippe Van der Linden, MD, Pr · CHU Brugmann

  • Brigitte Ickx, Md, Pr · Erasme

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-24
Primary Completion
2017-12-21
Completion
2017-12-21

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02312999 on ClinicalTrials.gov