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 :
Recruiting
First Posted : September 11, 2017
Last Update Posted : December 12, 2018
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Sponsor:
B. Braun Melsungen AG
Collaborators:
Fresenius Kabi
European Society of Anaesthesiology
Information provided by (Responsible Party):
B. Braun Melsungen AG
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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) |
| 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 : | June 17, 2020 |
| Estimated Study Completion Date : | June 17, 2020 |
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: Hydroxyethylstarch 130 |
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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: 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 ]
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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
| Belgium | |
| Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, Belgium | |
| Contact: David Kahn, Dr. | |
| Principal Investigator: David Kahn, Dr. | |
| Ghent University Hospital | Not yet recruiting |
| Ghent, Belgium | |
| Contact: Stefan De Hert, Prof. | |
| Principal Investigator: Stefan De Hert, Prof. | |
| Czechia | |
| Kolín Hospital | Not yet recruiting |
| Kolín, Czechia, 28020 | |
| Contact: Martin Novacek, Dr. | |
| Principal Investigator: Martin Novacek, Dr. | |
| Germany | |
| Universitätsklinikum Bonn | 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. | |
| University Hospital Schleswig-Holstein Campus Kiel | Not yet recruiting |
| Kiel, Germany, 24105 | |
| Contact: Matthias Gruenewald, Prof. Dr. med. | |
| Principal Investigator: Matthias Gruenewald, Prof. Dr. med. | |
| Klinikum Oldenburg AÖR | Recruiting |
| Oldenburg, Germany, 26133 | |
| Contact: Andreas Weyland, Prof. Dr. med. | |
| Principal Investigator: Andreas Weyland, Prof. Dr. med. | |
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, Prof. | |
| Contact: Thomas Scheeren, Prof. | |
| Principal Investigator: Thomas Scheeren, Prof. | |
| University Medical Center (UMC) Maastricht | Recruiting |
| Maastricht, Netherlands | |
| Contact: Wolfgang Buhre, Prof. | |
| Principal Investigator: Wolfgang Buhre, Prof. | |
| Spain | |
| Hospital Clinico Universitario Valencia | Recruiting |
| Valencia, Spain | |
| Contact: Javier Belda, Prof. | |
| Principal Investigator: Javier Belda, Prof. | |
| Hospital Universitari i Politecnic la Fe | Recruiting |
| Valencia, Spain | |
| Contact: Oscar Diaz-Cambronero, Dr. | |
| Principal Investigator: Oscar Diaz-Cambronero, Dr. | |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | December 12, 2018 |
| Last Verified: | December 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:
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HES Hydroxyethylstarch |
Additional relevant MeSH terms:
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Hypovolemia Pathologic Processes Pharmaceutical Solutions |
Hydroxyethyl Starch Derivatives Plasma Substitutes Blood Substitutes |