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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278548
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Information provided by (Responsible Party):
Fresenius Kabi

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2290 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
Actual Primary Completion Date : April 9, 2022
Estimated Study Completion Date : May 6, 2023

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: Hydroxyethyl starch 130/0.4

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: until 1 year after surgery ]
  2. Calculated red blood cell (RBC) loss [ Time Frame: on post-operative day 3 ]
  3. Estimated intra-operative blood loss [ Time Frame: end of surgery ]
  4. Coagulation [ Time Frame: until post-operative day 1 ]
  5. Inflammation [ Time Frame: until post-operative day 1 ]
  6. Adverse events [ Time Frame: until post-operative day 90 ]
  7. Major post-operative complications [ Time Frame: until post-operative day 90 ]
  8. Mortality [ Time Frame: 1 year ]
  9. Composite of mortality and major post-operative complications (including renal) [ Time Frame: until post-operative day 90 ]
  10. Total volume of administered investigational product [ Time Frame: until 24 hours after investigational product treatment start ]
  11. Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss] [ Time Frame: until post-operative day 3 ]
  12. Heart Rate [ Time Frame: until post-operative day 3 ]
  13. Body temperature [ Time Frame: until post-operative day 3 ]
  14. Mean arterial pressure [ Time Frame: until post-operative day 3, if available ]
  15. Systolic arterial blood pressure [ Time Frame: until end of surgery ]
  16. Diastolic arterial blood pressure [ Time Frame: until end of surgery ]
  17. Central venous pressure (if available) [ Time Frame: until end of surgery ]
  18. Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration] [ Time Frame: until 24 hours after investigational product treatment start ]
  19. Partial pressure of carbon dioxide [ Time Frame: until end of surgery ]
  20. Partial pressure of oxygen [ Time Frame: until end of surgery ]
  21. Bicarbonate [ Time Frame: until end of surgery ]
  22. Arterial oxygen saturation [ Time Frame: until end of surgery ]
  23. Haemoglobin [ Time Frame: until post-operative day 3 ]
  24. Haematocrit [ Time Frame: until post-operative day 3 ]
  25. pH [ Time Frame: until end of surgery ]
  26. Base Excess [ Time Frame: until end of surgery ]
  27. Lactate [ Time Frame: until post-operative day 3 ]
  28. Central venous oxygen saturation (if available) [ Time Frame: until post-operative day 1 ]
  29. Serum sodium [ Time Frame: until post-operative day 1 ]
  30. Serum potassium [ Time Frame: until post-operative day 1 ]
  31. Serum calcium [ Time Frame: until post-operative day 1 ]
  32. Serum chloride [ Time Frame: until post-operative day 1 ]
  33. Length of stay in the hospital/intensive care unit [ Time Frame: until post-operative day 90 ]
  34. Hours on mechanical ventilation [ Time Frame: until post-operative day 7 ]


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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 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)

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


Locations
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Sponsors and Collaborators
Fresenius Kabi
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Investigators
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Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT03278548    
Other Study ID Numbers: HC-G-H-1504
HE06-024-CP4 ( Other Identifier: Fresenius Kabi )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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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 Fresenius Kabi:
HES
HES 130
Hydroxyethyl starch
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes