Hypovolemia Due to Acute Blood Loss
Conditions
Keywords
Hydroxyethyl starch, HES, HES 130
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.
Interventions
DRUGVolulyte 6%
Solution for infusion
DRUGIonolyte
Solution for infusion
Sponsors
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Male or female adult patients ≥18 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum) (as soon as possible during emergency care) * Patients with blunt or penetrating trauma suffering from estimated blood loss of ≥ 500 ml * Initial surgery deemed necessary within 24 hrs after trauma * Deferred signed written informed consent form or as locally required * No signs of intracranial or cerebral hemorrhage * Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission. Exclusion: * Hypersensitivity to the active substances or to any of the other excipients of the Investigational Products * Body weight ≥ 140 kg * Patients expected to die within 24h after traumatic injury * Sepsis * Burns * Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic Renal Replacement Therapy * Critically ill patients (typically admitted to the intensive care unit) * Hyperhydration * Pulmonary edema * Dehydration * Hyperkalemia * Severe hypernatremia * Severe hyperchloremia * Severely impaired hepatic function * Congestive heart failure * Severe coagulopathy * Organ transplant patients * Metabolic alkalosis * Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Days on Renal Replacement Therapy | 90 days after randomization | — |
| Patients on Renal Replacement Therapy | 90 days after randomization | — |
| Platelet count | 3 days post-trauma | — |
| International normalized ratio | 3 days post-trauma | — |
| Activated partial thromboplastin time | 3 days post-trauma | — |
| 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 | — |
| 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 | — |
| Serum creatinine | 7 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 | — |
| Central venous oxygen saturation (if available) | 3 days post-trauma | — |
Countries
Belgium, Czechia, France, Germany, Netherlands, South Africa, Spain
Outcome results
None listed