Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

Conditions
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Hypovolemia Due to Acute Blood Loss

Intervention / Treatment
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* Drug: Volulyte 6%
* Drug: Ionolyte


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volulyte 6%<br>Volulyte 6% solution for infusion | Drug: Volulyte 6%<br>* Solution for infusion<br>* Other names: Hydroxyethyl starch 130;|
| Active Comparator: Ionolyte<br>Ionolyte solution for infusion | Drug: Ionolyte<br>* Solution for infusion<br>* Other names: Ionolyte Electrolyte Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 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 | 7 days post-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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxyethyl starch, HES, HES 130