Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
NCT ID: NCT03278548
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2289 participants
INTERVENTIONAL
2017-09-28
2022-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Volulyte 6%
Volulyte 6% solution for infusion
Volulyte 6%
Solution for infusion
Ionolyte
Ionolyte solution for infusion
Ionolyte
Solution for infusion
Interventions
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Volulyte 6%
Solution for infusion
Ionolyte
Solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
41 Years
85 Years
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
European Society of Anaesthesiology and Intensive Care
OTHER
Fresenius Kabi
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang F. Buhre, Prof. Dr. med.
Role: STUDY_CHAIR
Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
Locations
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General Hospital of Barmherzige Brüder
Sankt Veit, , Austria
Social Medical Center East - Donauspital
Vienna, , Austria
Cliniques Universitaires Saint Luc
Brussels, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Clinical Hospital Sveti Duh
Zagreb, , Croatia
University Hospital Sisters of Mercy
Zagreb, , Croatia
University Hospital Zagreb
Zagreb, , Croatia
Kolín Hospital
Kolín, , Czechia
Central Military Hospital Prague
Prague, , Czechia
General University Hospital in Prague
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
CHU Angers
Angers, , France
Hospital Centre Pierre Oudot
Bourgoin, , France
CHRU Lille
Lille, , France
Hospital Centre Montauban
Montauban, , France
Montpellier University Hospital
Montpellier, , France
AP-HP Paris (Salpêtrière)
Paris, , France
Hospital Saint-Antoine
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
University Hospital of Strasbourg
Strasbourg, , France
Hospital Foch Suresnes
Suresnes, , France
Hospital Jean Bernard
Valenciennes, , France
Kliniken der Stadt Köln
Cologne, , Germany
Carl-Thiem-Klinikum
Cottbus, , Germany
Helios Amper-Klinikum
Dachau, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
University Hospital Schleswig-Holstein Campus Kiel
Kiel, , Germany
University Hospital Marburg
Marburg, , Germany
University Hospital Munich
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Oldenburg AÖR
Oldenburg, , Germany
Regio Klinikum Pinneberg GmbH
Pinneberg, , Germany
Amsterdam Medical Centre
Amsterdam, , Netherlands
Martini General Hospital Groningen
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
University Medical Center (UMC) Maastricht
Maastricht, , Netherlands
University Clinical Center Gdansk
Gdansk, , Poland
Szpital Specjalistyczny im. Św. Łukasza
Gmina Końskie, , Poland
Medical University of Silesia
Katowice, , Poland
Wojewodzki Szpital Zespolony
Konin, , Poland
Jagiollonian University Hospital Medical College
Krakow, , Poland
Medical University of Lublin
Lublin, , Poland
Karol Marcinkowski Medical University in Poznań
Poznan, , Poland
University Hospital in Wroclaw
Wroclaw, , Poland
Klinika Wiśniowa
Zielona Góra, , Poland
Fundeni Clinical Institute 1
Bucharest, , Romania
Fundeni Clinical Institute 2
Bucharest, , Romania
University Hospital Elias Bucharest
Bucharest, , Romania
Emergency county hospital Cluj
Cluj-Napoca, , Romania
Barcelona Clinic Hospital
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
University Hospital General Del Elche
Elche, , Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Alcorcon
Madrid, , Spain
Quironsalud
Málaga, , Spain
Hospital Clinico Universitario Valencia
Valencia, , Spain
Hospital Universitari i Politecnic la Fe
Valencia, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Countries
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References
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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.
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.
Buhre W, Diaz-Cambronero O, Schaefer S, Novacek M, Domingo MS, Stessel B, Rodriguez-Perez A, Richter T, Rohe G, Cholley B, Gruenewald M, Kuiper G, Jaber S, de Korte D, Belda J, de Abreu MG, Baronica R, Scheeren T, Ferrando-Ortola C, Szczeklik W, Tomescu D, Vyzamal T, Gavranovic Z, Argente-Navarro MP, Mazzinari G, Thaler S, Garcia-Gregorio N, Vandenbrande J, Zlotnik D, Wittenstein J, Schmier S, Rohn S, Glasmacher C, Holler M, Jungheinrich C, Niess U, Sessler DI, Westphal M. Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial. Eur J Anaesthesiol. 2025 Oct 24. doi: 10.1097/EJA.0000000000002307. Online ahead of print.
Other Identifiers
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HE06-024-CP4
Identifier Type: OTHER
Identifier Source: secondary_id
HC-G-H-1504
Identifier Type: -
Identifier Source: org_study_id
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