Clinical trial NCT03278548: Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Official title: Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypovolaemia Due to Acute Blood Loss
Keywords: HES
HES 130
Hydroxyethyl starch
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: B. Braun Melsungen AG
name: European Society of Anaesthesiology and Intensive Care
First posted: 2017-09-11
Enrollment: 2289
Sex: ALL
Minimum age (years): 41
Maximum age (years): 85
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% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.


Eligibility criteria: Inclusion:

* Male or female adult patients \> 40 and ≤ 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
* Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
* ASA Physical Status II - III
* Signed written informed consent form

Exclusion:

* Hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products
* Body weight ≥ 140 kg
* Sepsis
* Burns
* Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic renal replacement therapy
* Intracranial or cerebral haemorrhage
* Critically ill patients (typically admitted to the intensive care unit)
* Hyperhydration
* Pulmonary oedema
* Dehydration
* Hyperkalaemia
* Severe hypernatraemia
* Severe hyperchloraemia
* 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: Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups
timeFrame: post-operative days 1-3
Secondary outcomes:
measure: Renal function
timeFrame: until 1 year after surgery
measure: Calculated red blood cell (RBC) loss
timeFrame: on post-operative day 3
measure: Estimated intra-operative blood loss
timeFrame: end of surgery
measure: Coagulation
timeFrame: until post-operative day 1
measure: Inflammation
timeFrame: until post-operative day 1
measure: Adverse events
timeFrame: until post-operative day 90
measure: Major post-operative complications
timeFrame: until post-operative day 90
measure: Mortality
timeFrame: 1 year
measure: Composite of mortality and major post-operative complications (including renal)
timeFrame: until post-operative day 90
measure: Total volume of administered investigational product
timeFrame: until 24 hours after investigational product treatment start
measure: 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 intra-operative blood loss]
timeFrame: until post-operative day 3
measure: Heart Rate
timeFrame: until post-operative day 3
measure: Body temperature
timeFrame: until post-operative day 3
measure: Mean arterial pressure
timeFrame: until post-operative day 3, if available
measure: Systolic arterial blood pressure
timeFrame: until end of surgery
measure: Diastolic arterial blood pressure
timeFrame: until end of surgery
measure: Central venous pressure (if available)
timeFrame: until end of surgery
measure: Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration]
timeFrame: until 24 hours after investigational product treatment start
measure: Partial pressure of carbon dioxide
timeFrame: until end of surgery
measure: Partial pressure of oxygen
timeFrame: until end of surgery
measure: Bicarbonate
timeFrame: until end of surgery
measure: Arterial oxygen saturation
timeFrame: until end of surgery
measure: Haemoglobin
timeFrame: until post-operative day 3
measure: Haematocrit
timeFrame: until post-operative day 3
measure: pH
timeFrame: until end of surgery
measure: Base Excess
timeFrame: until end of surgery
measure: Lactate
timeFrame: until post-operative day 3
measure: Central venous oxygen saturation (if available)
timeFrame: until post-operative day 1
measure: Serum sodium
timeFrame: until post-operative day 1
measure: Serum potassium
timeFrame: until post-operative day 1
measure: Serum calcium
timeFrame: until post-operative day 1
measure: Serum chloride
timeFrame: until post-operative day 1
measure: Length of stay in the hospital/intensive care unit
timeFrame: until post-operative day 90
measure: Hours on mechanical ventilation
timeFrame: until post-operative day 7
Other outcomes:
Locations:
city: Sankt Veit
country: Austria
facility: General Hospital of Barmherzige Brüder
city: Vienna
country: Austria
facility: Social Medical Center East - Donauspital
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: University Hospital Sisters of Mercy
city: Zagreb
country: Croatia
facility: University Hospital Zagreb
city: Kolín
country: Czechia
facility: Kolín Hospital
city: Prague
country: Czechia
facility: Central Military Hospital Prague
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: University Hospital Motol
city: Angers
country: France
facility: CHU Angers
city: Bourgoin-Jallieu
country: France
facility: Hospital Centre Pierre Oudot
city: Lille
country: France
facility: CHRU Lille
city: Montauban
country: France
facility: Hospital Centre Montauban
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Paris
country: France
facility: AP-HP Paris (Salpêtrière)
city: Paris
country: France
facility: Hospital Saint-Antoine
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Suresnes
country: France
facility: Hospital Foch Suresnes
city: Valenciennes
country: France
facility: Hospital Jean Bernard
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum
city: Dachau
country: Germany
facility: Helios Amper-Klinikum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein Campus Kiel
city: Köln
country: Germany
facility: Kliniken der Stadt Köln
city: Marburg
country: Germany
facility: University Hospital Marburg
city: München
country: Germany
facility: University Hospital Munich
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AÖR
city: Pinneberg
country: Germany
facility: Regio Klinikum Pinneberg GmbH
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Centre
city: Groningen
country: Netherlands
facility: Martini General Hospital Groningen
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: University Medical Center (UMC) Maastricht
city: Gdańsk
country: Poland
facility: University Clinical Center Gdansk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Konin
country: Poland
facility: Wojewodzki Szpital Zespolony
city: Końskie
country: Poland
facility: Szpital Specjalistyczny im. Św. Łukasza
city: Kraków
country: Poland
facility: Jagiollonian University Hospital Medical College
city: Lublin
country: Poland
facility: Medical University of Lublin
city: Poznań
country: Poland
facility: Karol Marcinkowski Medical University in Poznań
city: Wrocław
country: Poland
facility: University Hospital in Wroclaw
city: Zielona Góra
country: Poland
facility: Klinika Wiśniowa
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute 1
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute 2
city: Bucharest
country: Romania
facility: University Hospital Elias Bucharest
city: Cluj-Napoca
country: Romania
facility: Emergency county hospital Cluj
city: Barcelona
country: Spain
facility: Barcelona Clinic Hospital
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Elche
country: Spain
facility: University Hospital General Del Elche
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Málaga
country: Spain
facility: Quironsalud
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic la Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
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: Buhre W, de Korte-de Boer D, de Abreu MG, Scheeren T, Gruenewald M, Hoeft A, Spahn DR, Zarbock A, Daamen S, Westphal M, Brauer U, Dehnhardt T, Schmier S, Baron JF, De Hert S, Gavranovic Z, Cholley B, Vymazal T, Szczeklik W, Bornemann-Cimenti H, Soro Domingo MB, Grintescu I, Jankovic R, Belda J. Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study. Trials. 2022 Feb 22;23(1):168. doi: 10.1186/s13063-022-06058-6.
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.