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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 1 year ]
2. Calculated red blood cell (RBC) loss [ Time Frame: 1 day ]
3. Estimated intra-operative blood loss [ Time Frame: 1 day ]
4. Coagulation [ Time Frame: 1 day ]
5. Inflammation [ Time Frame: 1 day ]
6. Adverse events [ Time Frame: until post-operative day 90 ]
7. Cystatin C [ Time Frame: until post-operative day 90 ]
8. Major post-operative complications [ Time Frame: until post-operative day 90 ]
9. Mortality [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	41 Years to 85 Years (Adult, Senior)
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)

Contacts and Locations

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Locations

Germany
Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Klinikum Oldenburg AÖR
Oldenburg, Germany, 26133

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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