Clinical trial NCT03338218: Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypovolemia Due to Acute Blood Loss
Keywords: Hydroxyethyl starch
HES
HES 130
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: B. Braun Melsungen AG
name: European Society of Anaesthesiology and Intensive Care
First posted: 2017-11-09
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: 90 days
Secondary outcomes:
measure: Serum creatinine
timeFrame: 7 days post-trauma
measure: Serum creatinine-based estimated glomerular filtration rate
timeFrame: 7 days post-trauma
measure: Cystatin-C
timeFrame: 3 days post-trauma
measure: Cystatin-C-based mean estimated glomerular filtration rate
timeFrame: 3 days post-trauma
measure: AKIN stages
timeFrame: 7 days post-trauma
measure: Highest AKIN stage reached on each day during the first week
timeFrame: 7 days post-trauma
measure: RIFLE stages
timeFrame: 7 days post-trauma
measure: Urine output (if available)
timeFrame: 7 days post-trauma
measure: Days on Renal Replacement Therapy
timeFrame: 90 days after randomization
measure: Patients on Renal Replacement Therapy
timeFrame: 90 days after randomization
measure: Platelet count
timeFrame: 3 days post-trauma
measure: International normalized ratio
timeFrame: 3 days post-trauma
measure: Activated partial thromboplastin time
timeFrame: 3 days post-trauma
measure: Adverse Events
timeFrame: 90 days after randomization
measure: Mortality
timeFrame: 90 days after randomization
measure: Length of Stay in ICU/hospital
timeFrame: 90 days after randomization
measure: C-reactive protein
timeFrame: 3 days post-trauma
measure: Hours on mechanical ventilation
timeFrame: 7 days post-trauma
measure: Total volume of administered investigational products
timeFrame: until 24 hours after investigational product treatment start
measure: Fluid balance
timeFrame: 7 days post-trauma
measure: Heart rate
timeFrame: 7 days post-trauma
measure: Temperature
timeFrame: 7 days post-trauma
measure: Mean arterial pressure
timeFrame: 7 days post-trauma
measure: Systolic arterial blood pressure
timeFrame: 7 days post-trauma
measure: Diastolic arterial blood pressure
timeFrame: 7 days post-trauma
measure: Central venous pressure (if available)
timeFrame: 7 days post-trauma
measure: Partial pressure of carbon dioxide
timeFrame: 3 days post-trauma
measure: Partial pressure of oxygen
timeFrame: 3 days post-trauma
measure: Bicarbonate
timeFrame: 3 days post-trauma
measure: Arterial oxygen saturation
timeFrame: 3 days post-trauma
measure: Hemoglobin
timeFrame: 3 days post-trauma
measure: Hematocrit
timeFrame: 3 days post-trauma
measure: pH
timeFrame: 3 days post-trauma
measure: Base excess
timeFrame: 3 days post-trauma
measure: Lactate
timeFrame: 3 days post-trauma
measure: Central venous oxygen saturation (if available)
timeFrame: 3 days post-trauma
measure: Serum sodium
timeFrame: 3 days post-trauma
measure: Serum potassium
timeFrame: 3 days post-trauma
measure: Serum calcium
timeFrame: 3 days post-trauma
measure: Serum chloride
timeFrame: 3 days post-trauma
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg-ZOL
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Prague
country: Czechia
facility: Military University Hospital
city: Nancy
country: France
facility: CHRU Nancy - Hôpital Central
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein Campus Kiel
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC) Anesthesiology
city: Maastricht
country: Netherlands
facility: University Medical Center (UMC) Maastricht
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Germiston
country: South Africa
facility: Gama Research Centre Emergency Department, Leratong Hospital
city: Germiston
country: South Africa
facility: Gama Research Centre
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Kimberley
country: South Africa
facility: Trident Clinical, Homestead Medical Centre
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trials Centre
city: Worcester
country: South Africa
facility: Clinical Projects Research SA
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic la Fe
Study officials:
affiliation: Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
name: Wolfgang F. Buhre, Prof. Dr. med.
role: STUDY_CHAIR
References:
citation: Palma CD, Mamba M, Geldenhuys J, Fadahun O, Rossaint R, Zacharowski K, Brand M, Diaz-Cambronero O, Belda J, Westphal M, Brauer U, Dormann D, Dehnhardt T, Hernandez-Gonzalez M, Schmier S, de Korte D, Plani F, Buhre W. 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: study protocol for the TETHYS study. Trials. 2022 Jun 2;23(1):456. doi: 10.1186/s13063-022-06390-x.
citation: Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7. No abstract available.