Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
- Conditions
- Hypovolemia Due to Acute Blood Loss
- Interventions
- Registration Number
- NCT03338218
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
Not provided
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 Composite endpoint of 90 day mortality and 90 day renal failure defined as biomarker increase as defined by AKIN stage 2 or RIFLE injury stage or need for RRT at any time during the first 3 months. 90 days
- Secondary Outcome Measures
Name Time Method Central venous pressure (if available) 7 days post-trauma Partial pressure of carbon dioxide 3 days post-trauma Partial pressure of oxygen 3 days post-trauma Bicarbonate 3 days post-trauma Arterial oxygen saturation 3 days post-trauma Hemoglobin 3 days post-trauma Hematocrit 3 days post-trauma pH 3 days post-trauma Base excess 3 days post-trauma Lactate 3 days post-trauma Central venous oxygen saturation (if available) 3 days post-trauma Serum sodium 3 days post-trauma Serum potassium 3 days post-trauma Serum calcium 3 days post-trauma Serum chloride 3 days post-trauma Serum creatinine 7 days post-trauma Serum creatinine-based estimated glomerular filtration rate 7 days post-trauma Cystatin-C 3 days post-trauma Cystatin-C-based mean estimated glomerular filtration rate 3 days post-trauma AKIN stages 7 days post-trauma Days on Renal Replacement Therapy 90 days after randomization International normalized ratio 3 days post-trauma Activated partial thromboplastin time 3 days post-trauma Highest AKIN stage reached on each day during the first week 7 days post-trauma RIFLE stages 7 days post-trauma Urine output (if available) 7 days post-trauma Platelet count 3 days post-trauma Patients on Renal Replacement Therapy 90 days after randomization Adverse Events 90 days after randomization Mortality 90 days after randomization Length of Stay in ICU/hospital 90 days after randomization C-reactive protein 3 days post-trauma Hours on mechanical ventilation 7 days post-trauma Total volume of administered investigational products until 24 hours after investigational product treatment start Fluid balance 7 days post-trauma 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 due to surgeries and trauma
Heart rate 7 days post-trauma Temperature 7 days post-trauma Mean arterial pressure 7 days post-trauma Systolic arterial blood pressure 7 days post-trauma Diastolic arterial blood pressure 7 days post-trauma
Related Research Topics
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Trial Locations
- Locations (22)
Ziekenhuis Oost-Limburg-ZOL
🇧🇪Genk, Belgium
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Military University Hospital
🇨🇿Prague, Czechia
CHRU Nancy - Hôpital Central
🇫🇷Nancy, France
Hôpital de Hautepierre
🇫🇷Strasbourg, France
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
University Hospital Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Academic Medical Center (AMC) Anesthesiology
🇳🇱Amsterdam, Netherlands
Scroll for more (12 remaining)Ziekenhuis Oost-Limburg-ZOL🇧🇪Genk, Belgium