Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
PHOENICS
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
2 other identifiers
interventional
2,289
10 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2017
Longer than P75 for phase_4
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2022
CompletedJanuary 31, 2024
January 1, 2024
4.5 years
September 8, 2017
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
post-operative days 1-3
Secondary Outcomes (34)
Renal function
until 1 year after surgery
Calculated red blood cell (RBC) loss
on post-operative day 3
Estimated intra-operative blood loss
end of surgery
Coagulation
until post-operative day 1
Inflammation
until post-operative day 1
- +29 more secondary outcomes
Study Arms (2)
Volulyte 6%
EXPERIMENTALVolulyte 6% solution for infusion
Ionolyte
ACTIVE COMPARATORIonolyte solution for infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
- B. Braun Melsungen AGcollaborator
- European Society of Anaesthesiology and Intensive Carecollaborator
Study Sites (61)
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
Related Publications (3)
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. 2026 Jan 1;43(1):1-10. doi: 10.1097/EJA.0000000000002307. Epub 2025 Oct 24.
PMID: 41133731DERIVEDBuhre 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.
PMID: 35193648DERIVEDChappell 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.
PMID: 30017128DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wolfgang F. Buhre, Prof. Dr. med.
Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2017
First Posted
September 11, 2017
Study Start
September 28, 2017
Primary Completion
April 9, 2022
Study Completion
July 6, 2022
Last Updated
January 31, 2024
Record last verified: 2024-01