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

Fresenius Kabi238 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

238

Conditions

Hypovolemia Due to Acute Blood Loss

Interventions

Volulyte 6%DRUG

Solution for infusion

IonolyteDRUG

Solution for infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (22)

Ziekenhuis Oost-Limburg-ZOL

Genk, Belgium

Fakultni nemocnice Brno

Brno, Czechia

Outcomes

Primary Outcomes

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.

Time frame: 90 days