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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : May 24, 2022
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Sponsor:
Fresenius Kabi
Collaborators:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Information provided by (Responsible Party):
Fresenius Kabi
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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 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 |
|---|---|
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Experimental: Volulyte 6%
Volulyte 6% solution for infusion
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Drug: Volulyte 6%
Solution for infusion
Other Name: Hydroxyethyl starch 130/0.4 |
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Active Comparator: Ionolyte
Ionolyte solution for infusion
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Drug: Ionolyte
Solution for infusion
Other Name: Electrolyte solution |
Primary Outcome Measures :
- 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 :
- Renal function [ Time Frame: until 1 year after surgery ]
- Calculated red blood cell (RBC) loss [ Time Frame: on post-operative day 3 ]
- Estimated intra-operative blood loss [ Time Frame: end of surgery ]
- Coagulation [ Time Frame: until post-operative day 1 ]
- Inflammation [ Time Frame: until post-operative day 1 ]
- Adverse events [ Time Frame: until post-operative day 90 ]
- Major post-operative complications [ Time Frame: until post-operative day 90 ]
- Mortality [ Time Frame: 1 year ]
- Composite of mortality and major post-operative complications (including renal) [ Time Frame: until post-operative day 90 ]
- Total volume of administered investigational product [ Time Frame: until 24 hours after investigational product treatment start ]
- 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 ]
- Heart Rate [ Time Frame: until post-operative day 3 ]
- Body temperature [ Time Frame: until post-operative day 3 ]
- Mean arterial pressure [ Time Frame: until post-operative day 3, if available ]
- Systolic arterial blood pressure [ Time Frame: until end of surgery ]
- Diastolic arterial blood pressure [ Time Frame: until end of surgery ]
- Central venous pressure (if available) [ Time Frame: until end of surgery ]
- 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 ]
- Partial pressure of carbon dioxide [ Time Frame: until end of surgery ]
- Partial pressure of oxygen [ Time Frame: until end of surgery ]
- Bicarbonate [ Time Frame: until end of surgery ]
- Arterial oxygen saturation [ Time Frame: until end of surgery ]
- Haemoglobin [ Time Frame: until post-operative day 3 ]
- Haematocrit [ Time Frame: until post-operative day 3 ]
- pH [ Time Frame: until end of surgery ]
- Base Excess [ Time Frame: until end of surgery ]
- Lactate [ Time Frame: until post-operative day 3 ]
- Central venous oxygen saturation (if available) [ Time Frame: until post-operative day 1 ]
- Serum sodium [ Time Frame: until post-operative day 1 ]
- Serum potassium [ Time Frame: until post-operative day 1 ]
- Serum calcium [ Time Frame: until post-operative day 1 ]
- Serum chloride [ Time Frame: until post-operative day 1 ]
- Length of stay in the hospital/intensive care unit [ Time Frame: until post-operative day 90 ]
- 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
Show 61 study locations
Sponsors and Collaborators
Fresenius Kabi
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Investigators
| 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):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Fresenius Kabi:
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HES HES 130 Hydroxyethyl starch |
Additional relevant MeSH terms:
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Hypovolemia Pathologic Processes |