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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278548
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Information provided by (Responsible Party):
Fresenius Kabi

Tracking Information
First Submitted Date  ICMJE September 8, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date May 24, 2022
Actual Study Start Date  ICMJE September 28, 2017
Actual Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypovolaemia Due to Acute Blood Loss
Intervention  ICMJE
  • Drug: Volulyte 6%
    Solution for infusion
    Other Name: Hydroxyethyl starch 130/0.4
  • Drug: Ionolyte
    Solution for infusion
    Other Name: Electrolyte solution
Study Arms  ICMJE
  • Experimental: Volulyte 6%
    Volulyte 6% solution for infusion
    Intervention: Drug: Volulyte 6%
  • Active Comparator: Ionolyte
    Ionolyte solution for infusion
    Intervention: Drug: Ionolyte
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2022)
2290
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
2280
Estimated Study Completion Date  ICMJE May 6, 2023
Actual Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 41 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Croatia,   Czechia,   France,   Germany,   Netherlands,   Poland,   Romania,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278548
Other Study ID Numbers  ICMJE HC-G-H-1504
HE06-024-CP4 ( Other Identifier: Fresenius Kabi )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fresenius Kabi
Original Responsible Party B. Braun Melsungen AG
Current Study Sponsor  ICMJE Fresenius Kabi
Original Study Sponsor  ICMJE B. Braun Melsungen AG
Collaborators  ICMJE
  • B. Braun Melsungen AG
  • European Society of Anaesthesiology and Intensive Care
Investigators  ICMJE
Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
PRS Account Fresenius Kabi
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP