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Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

NCT03278548 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2289

Last updated 2024-01-31

No results posted yet for this study

Summary

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

Conditions

  • Hypovolaemia Due to Acute Blood Loss

Interventions

DRUG

Volulyte 6%

Solution for infusion

DRUG

Ionolyte

Solution for infusion

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • European Society of Anaesthesiology and Intensive Care

    collaborator OTHER

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Wolfgang F. Buhre, Prof. Dr. med. · Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2022-04-09
Completion
2022-07-06

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Germany
  • Netherlands
  • Poland
  • Romania
  • Spain

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 NCT03278548 on ClinicalTrials.gov