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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 6, 2018
Sponsor:
Collaborators:
Fresenius Kabi
European Society of Anaesthesiology
Information provided by (Responsible Party):
B. Braun Melsungen AG

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 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 : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




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 ]


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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)

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

Locations
Germany
Universitätsklinikum Bonn Not yet 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.         
Klinikum Oldenburg AÖR Recruiting
Oldenburg, Germany, 26133
Contact: Andreas Weyland, Prof. Dr. med.         
Principal Investigator: Andreas Weyland, Prof. Dr. med.         
Sponsors and Collaborators
B. Braun Melsungen AG
Fresenius Kabi
European Society of Anaesthesiology
Investigators
Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain management, Maastricht University

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 6, 2018
Last Verified: July 2018

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:
Hypovolemia
Pathologic Processes
Pharmaceutical Solutions
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes