Trials / Completed
CompletedNCT03278548
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,289 (actual)
- Sponsor
- Fresenius Kabi · Industry
- Sex
- All
- Age
- 41 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Volulyte 6% | Solution for infusion |
| DRUG | Ionolyte | Solution for infusion |
Timeline
- Start date
- 2017-09-28
- Primary completion
- 2022-04-09
- Completion
- 2022-07-06
- First posted
- 2017-09-11
- Last updated
- 2024-01-31
Locations
61 sites across 10 countries: Austria, Belgium, Croatia, Czechia, France, Germany, Netherlands, Poland, Romania, Spain
Source: ClinicalTrials.gov record NCT03278548. Inclusion in this directory is not an endorsement.