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

Primary Purpose

Hypovolaemia Due to Acute Blood Loss

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Volulyte 6%
Ionolyte
Sponsored by
Fresenius Kabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovolaemia Due to Acute Blood Loss focused on measuring HES, HES 130, Hydroxyethyl starch

Eligibility Criteria

41 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • General Hospital of Barmherzige Brüder
  • Social Medical Center East - Donauspital
  • Cliniques Universitaires Saint Luc
  • AZ Maria Middelares
  • Jessa Ziekenhuis
  • Clinical Hospital Sveti Duh
  • University Hospital Sisters of Mercy
  • University Hospital Zagreb
  • Kolín Hospital
  • Central Military Hospital Prague
  • General University Hospital in Prague
  • University Hospital Motol
  • CHU Angers
  • Hospital Centre Pierre Oudot
  • CHRU Lille
  • Hospital Centre Montauban
  • Montpellier University Hospital
  • AP-HP Paris (Salpêtrière)
  • Hospital Saint-Antoine
  • Hôpital Européen Georges Pompidou
  • University Hospital of Strasbourg
  • Hospital Foch Suresnes
  • Hospital Jean Bernard
  • Carl-Thiem-Klinikum
  • Helios Amper-Klinikum
  • Universitätsklinikum Carl Gustav Carus
  • University Hospital Schleswig-Holstein Campus Kiel
  • Kliniken der Stadt Köln
  • University Hospital Marburg
  • University Hospital Munich
  • Universitätsklinikum Münster
  • Klinikum Oldenburg AÖR
  • Regio Klinikum Pinneberg GmbH
  • Amsterdam Medical Centre
  • Martini General Hospital Groningen
  • University Medical Center Groningen
  • University Medical Center (UMC) Maastricht
  • University Clinical Center Gdansk
  • Medical University of Silesia
  • Wojewodzki Szpital Zespolony
  • Szpital Specjalistyczny im. Św. Łukasza
  • Jagiollonian University Hospital Medical College
  • Medical University of Lublin
  • Karol Marcinkowski Medical University in Poznań
  • University Hospital in Wroclaw
  • Klinika Wiśniowa
  • Fundeni Clinical Institute 1
  • Fundeni Clinical Institute 2
  • University Hospital Elias Bucharest
  • Emergency county hospital Cluj
  • Barcelona Clinic Hospital
  • Hospital Santa Creu i Sant Pau
  • University Hospital General Del Elche
  • Hospital Universitario de Gran Canaria Dr. Negrín
  • Hospital Gregorio Marañon
  • Hospital Ramón y Cajal
  • Hospital Universitario Fundacion Alcorcon
  • Quironsalud
  • Hospital Clinico Universitario Valencia
  • Hospital Universitari i Politecnic la Fe
  • Hospital Universitario Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Volulyte 6%

Ionolyte

Arm Description

Volulyte 6% solution for infusion

Ionolyte solution for infusion

Outcomes

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

Secondary Outcome Measures

Renal function
Calculated red blood cell (RBC) loss
Estimated intra-operative blood loss
Coagulation
Inflammation
Adverse events
Major post-operative complications
Mortality
Composite of mortality and major post-operative complications (including renal)
Total volume of administered investigational product
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]
Heart Rate
Body temperature
Mean arterial pressure
Systolic arterial blood pressure
Diastolic arterial blood pressure
Central venous pressure (if available)
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]
Partial pressure of carbon dioxide
Partial pressure of oxygen
Bicarbonate
Arterial oxygen saturation
Haemoglobin
Haematocrit
pH
Base Excess
Lactate
Central venous oxygen saturation (if available)
Serum sodium
Serum potassium
Serum calcium
Serum chloride
Length of stay in the hospital/intensive care unit
Hours on mechanical ventilation

Full Information

First Posted
September 8, 2017
Last Updated
August 8, 2023
Sponsor
Fresenius Kabi
Collaborators
B. Braun Melsungen AG, European Society of Anaesthesiology and Intensive Care
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1. Study Identification

Unique Protocol Identification Number
NCT03278548
Brief Title
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi
Collaborators
B. Braun Melsungen AG, European Society of Anaesthesiology and Intensive Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolaemia Due to Acute Blood Loss
Keywords
HES, HES 130, Hydroxyethyl starch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volulyte 6%
Arm Type
Experimental
Arm Description
Volulyte 6% solution for infusion
Arm Title
Ionolyte
Arm Type
Active Comparator
Arm Description
Ionolyte solution for infusion
Intervention Type
Drug
Intervention Name(s)
Volulyte 6%
Other Intervention Name(s)
Hydroxyethyl starch 130/0.4
Intervention Description
Solution for infusion
Intervention Type
Drug
Intervention Name(s)
Ionolyte
Other Intervention Name(s)
Electrolyte solution
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Renal function
Time Frame
until 1 year after surgery
Title
Calculated red blood cell (RBC) loss
Time Frame
on post-operative day 3
Title
Estimated intra-operative blood loss
Time Frame
end of surgery
Title
Coagulation
Time Frame
until post-operative day 1
Title
Inflammation
Time Frame
until post-operative day 1
Title
Adverse events
Time Frame
until post-operative day 90
Title
Major post-operative complications
Time Frame
until post-operative day 90
Title
Mortality
Time Frame
1 year
Title
Composite of mortality and major post-operative complications (including renal)
Time Frame
until post-operative day 90
Title
Total volume of administered investigational product
Time Frame
until 24 hours after investigational product treatment start
Title
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
Title
Heart Rate
Time Frame
until post-operative day 3
Title
Body temperature
Time Frame
until post-operative day 3
Title
Mean arterial pressure
Time Frame
until post-operative day 3, if available
Title
Systolic arterial blood pressure
Time Frame
until end of surgery
Title
Diastolic arterial blood pressure
Time Frame
until end of surgery
Title
Central venous pressure (if available)
Time Frame
until end of surgery
Title
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
Title
Partial pressure of carbon dioxide
Time Frame
until end of surgery
Title
Partial pressure of oxygen
Time Frame
until end of surgery
Title
Bicarbonate
Time Frame
until end of surgery
Title
Arterial oxygen saturation
Time Frame
until end of surgery
Title
Haemoglobin
Time Frame
until post-operative day 3
Title
Haematocrit
Time Frame
until post-operative day 3
Title
pH
Time Frame
until end of surgery
Title
Base Excess
Time Frame
until end of surgery
Title
Lactate
Time Frame
until post-operative day 3
Title
Central venous oxygen saturation (if available)
Time Frame
until post-operative day 1
Title
Serum sodium
Time Frame
until post-operative day 1
Title
Serum potassium
Time Frame
until post-operative day 1
Title
Serum calcium
Time Frame
until post-operative day 1
Title
Serum chloride
Time Frame
until post-operative day 1
Title
Length of stay in the hospital/intensive care unit
Time Frame
until post-operative day 90
Title
Hours on mechanical ventilation
Time Frame
until post-operative day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang F. Buhre, Prof. Dr. med.
Organizational Affiliation
Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Barmherzige Brüder
City
Sankt Veit
Country
Austria
Facility Name
Social Medical Center East - Donauspital
City
Vienna
Country
Austria
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
Country
Belgium
Facility Name
Clinical Hospital Sveti Duh
City
Zagreb
Country
Croatia
Facility Name
University Hospital Sisters of Mercy
City
Zagreb
Country
Croatia
Facility Name
University Hospital Zagreb
City
Zagreb
Country
Croatia
Facility Name
Kolín Hospital
City
Kolín
Country
Czechia
Facility Name
Central Military Hospital Prague
City
Prague
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
Country
Czechia
Facility Name
University Hospital Motol
City
Prague
Country
Czechia
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
Hospital Centre Pierre Oudot
City
Bourgoin-Jallieu
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
Hospital Centre Montauban
City
Montauban
Country
France
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France
Facility Name
AP-HP Paris (Salpêtrière)
City
Paris
Country
France
Facility Name
Hospital Saint-Antoine
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
University Hospital of Strasbourg
City
Strasbourg
Country
France
Facility Name
Hospital Foch Suresnes
City
Suresnes
Country
France
Facility Name
Hospital Jean Bernard
City
Valenciennes
Country
France
Facility Name
Carl-Thiem-Klinikum
City
Cottbus
Country
Germany
Facility Name
Helios Amper-Klinikum
City
Dachau
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
University Hospital Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Facility Name
Kliniken der Stadt Köln
City
Köln
Country
Germany
Facility Name
University Hospital Marburg
City
Marburg
Country
Germany
Facility Name
University Hospital Munich
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Klinikum Oldenburg AÖR
City
Oldenburg
Country
Germany
Facility Name
Regio Klinikum Pinneberg GmbH
City
Pinneberg
Country
Germany
Facility Name
Amsterdam Medical Centre
City
Amsterdam
Country
Netherlands
Facility Name
Martini General Hospital Groningen
City
Groningen
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
University Medical Center (UMC) Maastricht
City
Maastricht
Country
Netherlands
Facility Name
University Clinical Center Gdansk
City
Gdańsk
Country
Poland
Facility Name
Medical University of Silesia
City
Katowice
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony
City
Konin
Country
Poland
Facility Name
Szpital Specjalistyczny im. Św. Łukasza
City
Końskie
Country
Poland
Facility Name
Jagiollonian University Hospital Medical College
City
Kraków
Country
Poland
Facility Name
Medical University of Lublin
City
Lublin
Country
Poland
Facility Name
Karol Marcinkowski Medical University in Poznań
City
Poznań
Country
Poland
Facility Name
University Hospital in Wroclaw
City
Wrocław
Country
Poland
Facility Name
Klinika Wiśniowa
City
Zielona Góra
Country
Poland
Facility Name
Fundeni Clinical Institute 1
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute 2
City
Bucharest
Country
Romania
Facility Name
University Hospital Elias Bucharest
City
Bucharest
Country
Romania
Facility Name
Emergency county hospital Cluj
City
Cluj-Napoca
Country
Romania
Facility Name
Barcelona Clinic Hospital
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
University Hospital General Del Elche
City
Elche
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Madrid
Country
Spain
Facility Name
Quironsalud
City
Málaga
Country
Spain
Facility Name
Hospital Clinico Universitario Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politecnic la Fe
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35193648
Citation
Buhre W, de Korte-de Boer D, de Abreu MG, Scheeren T, Gruenewald M, Hoeft A, Spahn DR, Zarbock A, Daamen S, Westphal M, Brauer U, Dehnhardt T, Schmier S, Baron JF, De Hert S, Gavranovic Z, Cholley B, Vymazal T, Szczeklik W, Bornemann-Cimenti H, Soro Domingo MB, Grintescu I, Jankovic R, Belda J. Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study. Trials. 2022 Feb 22;23(1):168. doi: 10.1186/s13063-022-06058-6.
Results Reference
derived
PubMed Identifier
30017128
Citation
Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7. No abstract available.
Results Reference
derived

Learn more about this trial

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

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