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Completed

NCT Number: NCT03278548

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

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.

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Key information

Conditions

Hypovolaemia Due to Acute Blood Loss

Age range

41 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of Barmherzige Brüder, Sankt Veit, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Volulyte 6%

Drug

Solution for infusion

Other names: Hydroxyethyl starch 130/0.4

Ionolyte

Drug

Solution for infusion

Other names: Electrolyte solution

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

    Time frame: post-operative days 1-3

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Collaborators

  • B. Braun Melsungen AG
  • European Society of Anaesthesiology and Intensive Care

Registry information

Official study 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

Acronym: PHOENICS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 11, 2017
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.