ClinicalTrials.gov

History of Changes for Study: NCT03278548
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery (PHOENICS)
Latest version (submitted May 23, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 September 8, 2017 None (earliest Version on record)
2 September 11, 2017 Study Status and Conditions
3 September 20, 2017 Sponsor/Collaborators and Study Status
4 October 6, 2017 Recruitment Status, Study Status and Contacts/Locations
5 February 7, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 April 26, 2018 Study Status
7 May 11, 2018 Study Status
8 July 4, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 December 11, 2018 Study Status and Contacts/Locations
10 February 28, 2019 Contacts/Locations and Study Status
11 April 1, 2019 Contacts/Locations and Study Status
12 April 10, 2019 Study Status and Contacts/Locations
13 July 10, 2019 Study Status and Contacts/Locations
14 September 16, 2019 Contacts/Locations and Study Status
15 February 28, 2020 Study Status and Eligibility
16 November 12, 2021 Contacts/Locations, Sponsor/Collaborators, Study Status, Outcome Measures, Study Identification, Eligibility, Arms and Interventions, Conditions and Oversight
17 May 23, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT03278548
Submitted Date:  September 8, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: HC-G-H-1504
Brief Title: Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery (PHOENICS)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2017
Overall Status: Not yet recruiting
Study Start: September 2017
Primary Completion: December 2018 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: September 8, 2017
First Submitted that
Met QC Criteria:
September 8, 2017
First Posted: September 11, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 8, 2017
Last Update Posted: September 11, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: B. Braun Melsungen AG
Responsible Party: Sponsor
Collaborators: Fresenius Kabi
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Treatment of Hypovolaemia Due to Acute Blood Loss in Elective Abdominal Surgery
Keywords: HES
Hydroxyethylstarch
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 2280 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
Drug: Volulyte 6%
Solution for infusion
Other Names:
  • Hydroxyethylstarch 130
Active Comparator: Ionolyte
Ionolyte solution for infusion
Drug: Ionolyte
Solution for infusion
Other Names:
  • Electrolyte solution
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 41 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Study Manager
Telephone: +49-5661-71-0
Email: studies@bbraun.com
Study Officials: Wolfgang F. Buhre, Prof. Dr. med.
Study Chair
Department of Anesthesiology and Pain management, Maastricht University
Locations: Germany
Universitätsklinikum Bonn
Bonn, Germany, 53127
Contact:Contact: Maria Wittmann, Prof. Dr. med.
Contact:Principal Investigator: Maria Wittmann, Prof. Dr. med.
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Contact:Contact: Marcelo Gama de Abreu, Prof. Dr. med.
Contact:Principal Investigator: Marcelo Gama de Abreu, Prof. Dr. med.
Klinikum Oldenburg AÖR
Oldenburg, Germany, 26133
Contact:Contact: Andreas Weyland, Prof. Dr. med.
Contact:Principal Investigator: Andreas Weyland, Prof. Dr. med.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services