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
:
Active, not recruiting
First Posted
: September 11, 2017
Last Update Posted
: February 8, 2018
|
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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 : | 26 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 : | December 2018 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
|
Drug: Volulyte 6%
Solution for infusion
Other Name: Hydroxyethylstarch 130
|
Active Comparator: Ionolyte
Ionolyte solution for infusion
|
Drug: Ionolyte
Solution for infusion
Other Name: Electrolyte solution
|
- 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 ]
- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Germany | |
Universitätsklinikum Bonn | |
Bonn, Germany, 53127 | |
Universitätsklinikum Carl Gustav Carus | |
Dresden, Germany, 01307 | |
Klinikum Oldenburg AÖR | |
Oldenburg, Germany, 26133 |
Study Chair: | Wolfgang F. Buhre, Prof. Dr. med. | Department of Anesthesiology and Pain management, Maastricht University |
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: | February 8, 2018 |
Last Verified: | February 2017 |
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:
HES Hydroxyethylstarch |
Additional relevant MeSH terms:
Hypovolemia Pathologic Processes Pharmaceutical Solutions |
Hydroxyethyl Starch Derivatives Plasma Substitutes Blood Substitutes |