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Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery (PHOENICS)

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ClinicalTrials.gov Identifier: NCT03278548
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Fresenius Kabi
European Society of Anaesthesiology
Information provided by (Responsible Party):
B. Braun Melsungen AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypovolaemia Due to Acute Blood Loss Drug: Volulyte 6% Drug: Ionolyte Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
 Drug: Volulyte 6%
Solution for infusion
Other Name: Hydroxyethylstarch 130
Active Comparator: Ionolyte
Ionolyte solution for infusion
 Drug: Ionolyte
Solution for infusion
Other Name: Electrolyte solution


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: post-operative days 1-3 ]

Secondary Outcome Measures :
  1. Renal function [ Time Frame: 1 year ]
  2. Calculated red blood cell (RBC) loss [ Time Frame: 1 day ]
  3. Estimated intra-operative blood loss [ Time Frame: 1 day ]
  4. Coagulation [ Time Frame: 1 day ]
  5. Inflammation [ Time Frame: 1 day ]
  6. Adverse events [ Time Frame: until post-operative day 90 ]
  7. Cystatin C [ Time Frame: until post-operative day 90 ]
  8. Major post-operative complications [ Time Frame: until post-operative day 90 ]
  9. Mortality [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   41 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278548


Contacts
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Contact: Study Manager +49-5661-71-0 studies@bbraun.com

Locations
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Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium
Contact: David Kahn, Dr.         
Principal Investigator: David Kahn, Dr.         
Ghent University Hospital Not yet recruiting
Ghent, Belgium
Contact: Stefan De Hert, Prof.         
Principal Investigator: Stefan De Hert, Prof.         
Czechia
Kolín Hospital Recruiting
Kolín, Czechia, 28020
Contact: Martin Novacek, Dr.         
Principal Investigator: Martin Novacek, Dr.         
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Contact: Maria Wittmann, Prof. Dr. med.         
Principal Investigator: Maria Wittmann, Prof. Dr. med.         
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Marcelo Gama de Abreu, Prof. Dr. med.         
Principal Investigator: Marcelo Gama de Abreu, Prof. Dr. med.         
University Hospital Schleswig-Holstein Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Matthias Gruenewald, Prof. Dr. med.         
Principal Investigator: Matthias Gruenewald, Prof. Dr. med.         
Kliniken der Stadt Köln Recruiting
Köln, Germany
Contact: Frank Wappler, Prof. Dr. med.         
Principal Investigator: Frank Wappler, Prof. Dr. med.         
Universitätsklinikum Muenster Recruiting
Muenster, Germany
Contact: Alexander Zarbock, Prof. Dr. med.         
Principal Investigator: Alexander Zarbock, Prof. Dr. med.         
Klinikum Oldenburg AÖR Recruiting
Oldenburg, Germany, 26133
Contact: Andreas Weyland, Prof. Dr. med.         
Principal Investigator: Andreas Weyland, Prof. Dr. med.         
Netherlands
Amsterdam Medical Centre Recruiting
Amsterdam, Netherlands
Contact: Markus Hollmann, Prof. Dr. Dr.         
Principal Investigator: Markus Hollmann, Prof. Dr. Dr.         
University Medical Center Groningen Recruiting
Groningen, Netherlands, Prof. Dr.
Contact: Thomas Scheeren, Prof. Dr.         
Principal Investigator: Thomas Scheeren, Prof.         
University Medical Center (UMC) Maastricht Recruiting
Maastricht, Netherlands
Contact: Wolfgang Buhre, Prof. Dr.         
Principal Investigator: Wolfgang Buhre, Prof. Dr.         
Spain
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Victoria Moral, Dr.         
Principal Investigator: Victoria Moral, Dr.         
Hospital Universitario de Gran Canaria Dr. Negrín Recruiting
Las Palmas de Gran Canaria, Spain
Contact: Aurelio Rodríguez-Pérez, Prof. Dr.         
Principal Investigator: Aurelio Rodríguez-Pérez, Prof. Dr.         
Hospital Gregorio Marañon Recruiting
Madrid, Spain
Contact: Ignacio Garutti, Prof. Dr.         
Principal Investigator: Ignacio Garutti, Prof. Dr.         
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Contact: Nilda Martinez-Castro, Dr.         
Principal Investigator: Nilda Martinez-Castro, Dr.         
Hospital Universitario Fundacion Alcorcon Recruiting
Madrid, Spain
Contact: Santiago Garcia del Valle, Dr.         
Principal Investigator: Santiago Garcia del Valle, Dr.         
Hospital Clinico Universitario Valencia Recruiting
Valencia, Spain
Contact: Javier Belda, Prof.         
Principal Investigator: Javier Belda, Prof.         
Hospital Universitari i Politecnic la Fe Recruiting
Valencia, Spain
Contact: Oscar Diaz-Cambronero, Dr.         
Principal Investigator: Oscar Diaz-Cambronero, Dr.         
Hospital Universitario Rio Hortega Recruiting
Valladolid, Spain
Contact: César Aldecoa, Prof.         
Principal Investigator: César Aldecoa, Dr.         
Sponsors and Collaborators
B. Braun Melsungen AG
Fresenius Kabi
European Society of Anaesthesiology
Investigators
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Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain management, Maastricht University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT03278548     History of Changes
Other Study ID Numbers: HC-G-H-1504
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by B. Braun Melsungen AG:
HES
Hydroxyethylstarch

Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes
Hydroxyethyl Starch Derivatives
 Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes