Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Phase 4
Completed
- Conditions
- Hypovolaemia Due to Acute Blood Loss
- Interventions
- Registration Number
- NCT03278548
- Lead Sponsor
- Fresenius Kabi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2289
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Volulyte 6% Volulyte 6% Volulyte 6% solution for infusion Ionolyte Ionolyte Ionolyte solution for infusion
- Primary Outcome Measures
Name Time Method Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups post-operative days 1-3
- Secondary Outcome Measures
Name Time Method Coagulation until post-operative day 1 Serum chloride until post-operative day 1 Major post-operative complications until post-operative day 90 Mortality 1 year Composite of mortality and major post-operative complications (including renal) until post-operative day 90 Total volume of administered investigational product until 24 hours after investigational product treatment start Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss] until post-operative day 3 Heart Rate until post-operative day 3 Renal function until 1 year after surgery Calculated red blood cell (RBC) loss on post-operative day 3 Inflammation until post-operative day 1 Estimated intra-operative blood loss end of surgery Adverse events until post-operative day 90 Body temperature until post-operative day 3 Mean arterial pressure until post-operative day 3, if available Systolic arterial blood pressure until end of surgery Diastolic arterial blood pressure until end of surgery Central venous pressure (if available) until end of surgery Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration] until 24 hours after investigational product treatment start Partial pressure of carbon dioxide until end of surgery Partial pressure of oxygen until end of surgery Bicarbonate until end of surgery Arterial oxygen saturation until end of surgery Haemoglobin until post-operative day 3 Haematocrit until post-operative day 3 pH until end of surgery Base Excess until end of surgery Lactate until post-operative day 3 Central venous oxygen saturation (if available) until post-operative day 1 Serum sodium until post-operative day 1 Serum potassium until post-operative day 1 Serum calcium until post-operative day 1 Length of stay in the hospital/intensive care unit until post-operative day 90 Hours on mechanical ventilation until post-operative day 7
Trial Locations
- Locations (61)
General Hospital of Barmherzige Brüder
🇦🇹Sankt Veit, Austria
Social Medical Center East - Donauspital
🇦🇹Vienna, Austria
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Clinical Hospital Sveti Duh
🇭🇷Zagreb, Croatia
University Hospital Sisters of Mercy
🇭🇷Zagreb, Croatia
University Hospital Zagreb
🇭🇷Zagreb, Croatia
Kolín Hospital
🇨🇿Kolín, Czechia
Central Military Hospital Prague
🇨🇿Prague, Czechia
Scroll for more (51 remaining)General Hospital of Barmherzige Brüder🇦🇹Sankt Veit, Austria