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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 : March 2, 2020
Sponsor:
Collaborators:
Fresenius Kabi
European Society of Anaesthesiology
Information provided by (Responsible Party):
B. Braun Melsungen AG

Tracking Information
First Submitted Date  ICMJE September 8, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE September 28, 2017
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Renal function [ Time Frame: 1 year ]
  • Calculated red blood cell (RBC) loss [ Time Frame: 1 day ]
  • Estimated intra-operative blood loss [ Time Frame: 1 day ]
  • Coagulation [ Time Frame: 1 day ]
  • Inflammation [ Time Frame: 1 day ]
  • Adverse events [ Time Frame: until post-operative day 90 ]
  • Cystatin C [ Time Frame: until post-operative day 90 ]
  • Major post-operative complications [ Time Frame: until post-operative day 90 ]
  • Mortality [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypovolaemia Due to Acute Blood Loss
Intervention  ICMJE
  • Drug: Volulyte 6%
    Solution for infusion
    Other Name: Hydroxyethylstarch 130
  • Drug: Ionolyte
    Solution for infusion
    Other Name: Electrolyte solution
Study Arms  ICMJE
  • Experimental: Volulyte 6%
    Volulyte 6% solution for infusion
    Intervention: Drug: Volulyte 6%
  • Active Comparator: Ionolyte
    Ionolyte solution for infusion
    Intervention: Drug: Ionolyte
Publications * Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
2280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 17, 2020
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 41 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Manager +49-5661-71-0 studies@bbraun.com
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278548
Other Study ID Numbers  ICMJE HC-G-H-1504
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party B. Braun Melsungen AG
Study Sponsor  ICMJE B. Braun Melsungen AG
Collaborators  ICMJE
  • Fresenius Kabi
  • European Society of Anaesthesiology
Investigators  ICMJE
Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain management, Maastricht University
PRS Account B. Braun Melsungen AG
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP