Clincosm LogoSign in Get a demo

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

Sponsor
Fresenius Kabi (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03278548
Collaborator
B. Braun Melsungen AG (Industry), European Society of Anaesthesiology and Intensive Care (Other)
2,290
Enrollment
61
Locations
2
Arms
67.2
Anticipated Duration (Months)
37.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2290 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 :
Sep 28, 2017
Actual Primary Completion Date :
Apr 9, 2022
Anticipated Study Completion Date :
May 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Volulyte 6%

Volulyte 6% solution for infusion

Drug: Volulyte 6%
Solution for infusion
Other Names:
  • Hydroxyethyl starch 130/0.4

    		•
    Active Comparator: Ionolyte

    Ionolyte solution for infusion

    Drug: Ionolyte
    Solution for infusion
    Other Names:
  • Electrolyte solution

    		•

    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 [post-operative days 1-3]

    Secondary Outcome Measures

    1. Renal function [until 1 year after surgery]

    2. Calculated red blood cell (RBC) loss [on post-operative day 3]

    3. Estimated intra-operative blood loss [end of surgery]

    4. Coagulation [until post-operative day 1]

    5. Inflammation [until post-operative day 1]

    6. Adverse events [until post-operative day 90]

    7. Major post-operative complications [until post-operative day 90]

    8. Mortality [1 year]

    9. Composite of mortality and major post-operative complications (including renal) [until post-operative day 90]

    10. Total volume of administered investigational product [until 24 hours after investigational product treatment start]

    11. 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] [until post-operative day 3]

    12. Heart Rate [until post-operative day 3]

    13. Body temperature [until post-operative day 3]

    14. Mean arterial pressure [until post-operative day 3, if available]

    15. Systolic arterial blood pressure [until end of surgery]

    16. Diastolic arterial blood pressure [until end of surgery]

    17. Central venous pressure (if available) [until end of surgery]

    18. 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] [until 24 hours after investigational product treatment start]

    19. Partial pressure of carbon dioxide [until end of surgery]

    20. Partial pressure of oxygen [until end of surgery]

    21. Bicarbonate [until end of surgery]

    22. Arterial oxygen saturation [until end of surgery]

    23. Haemoglobin [until post-operative day 3]

    24. Haematocrit [until post-operative day 3]

    25. pH [until end of surgery]

    26. Base Excess [until end of surgery]

    27. Lactate [until post-operative day 3]

    28. Central venous oxygen saturation (if available) [until post-operative day 1]

    29. Serum sodium [until post-operative day 1]

    30. Serum potassium [until post-operative day 1]

    31. Serum calcium [until post-operative day 1]

    32. Serum chloride [until post-operative day 1]

    33. Length of stay in the hospital/intensive care unit [until post-operative day 90]

    34. Hours on mechanical ventilation [until post-operative day 7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    41 Years to 85 Years
    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 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of Barmherzige Brüder Sankt Veit Austria
    2 Social Medical Center East - Donauspital Vienna Austria
    3 Cliniques Universitaires Saint Luc Brussels Belgium
    4 AZ Maria Middelares Gent Belgium
    5 Jessa Ziekenhuis Hasselt Belgium
    6 Clinical Hospital Sveti Duh Zagreb Croatia
    7 University Hospital Sisters of Mercy Zagreb Croatia
    8 University Hospital Zagreb Zagreb Croatia
    9 Kolín Hospital Kolín Czechia
    10 Central Military Hospital Prague Prague Czechia
    11 General University Hospital in Prague Prague Czechia
    12 University Hospital Motol Prague Czechia
    13 CHU Angers Angers France
    14 Hospital Centre Pierre Oudot Bourgoin-Jallieu France
    15 CHRU Lille Lille France
    16 Hospital Centre Montauban Montauban France
    17 Montpellier University Hospital Montpellier France
    18 AP-HP Paris (Salpêtrière) Paris France
    19 Hospital Saint-Antoine Paris France
    20 Hôpital Européen Georges Pompidou Paris France
    21 University Hospital of Strasbourg Strasbourg France
    22 Hospital Foch Suresnes Suresnes France
    23 Hospital Jean Bernard Valenciennes France
    24 Carl-Thiem-Klinikum Cottbus Germany
    25 Helios Amper-Klinikum Dachau Germany
    26 Universitätsklinikum Carl Gustav Carus Dresden Germany
    27 University Hospital Schleswig-Holstein Campus Kiel Kiel Germany
    28 Kliniken der Stadt Köln Köln Germany
    29 University Hospital Marburg Marburg Germany
    30 University Hospital Munich München Germany
    31 Universitätsklinikum Münster Münster Germany
    32 Klinikum Oldenburg AÖR Oldenburg Germany
    33 Regio Klinikum Pinneberg GmbH Pinneberg Germany
    34 Amsterdam Medical Centre Amsterdam Netherlands
    35 Martini General Hospital Groningen Groningen Netherlands
    36 University Medical Center Groningen Groningen Netherlands
    37 University Medical Center (UMC) Maastricht Maastricht Netherlands
    38 University Clinical Center Gdansk Gdańsk Poland
    39 Medical University of Silesia Katowice Poland
    40 Wojewodzki Szpital Zespolony Konin Poland
    41 Szpital Specjalistyczny im. Św. Łukasza Końskie Poland
    42 Jagiollonian University Hospital Medical College Kraków Poland
    43 Medical University of Lublin Lublin Poland
    44 Karol Marcinkowski Medical University in Poznań Poznań Poland
    45 University Hospital in Wroclaw Wrocław Poland
    46 Klinika Wiśniowa Zielona Góra Poland
    47 Fundeni Clinical Institute 1 Bucharest Romania
    48 Fundeni Clinical Institute 2 Bucharest Romania
    49 University Hospital Elias Bucharest Bucharest Romania
    50 Emergency county hospital Cluj Cluj-Napoca Romania
    51 Barcelona Clinic Hospital Barcelona Spain
    52 Hospital Santa Creu i Sant Pau Barcelona Spain
    53 University Hospital General Del Elche Elche Spain
    54 Hospital Universitario de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria Spain
    55 Hospital Gregorio Marañon Madrid Spain
    56 Hospital Ramón y Cajal Madrid Spain
    57 Hospital Universitario Fundacion Alcorcon Madrid Spain
    58 Quironsalud Málaga Spain
    59 Hospital Clinico Universitario Valencia Valencia Spain
    60 Hospital Universitari i Politecnic la Fe Valencia Spain
    61 Hospital Universitario Rio Hortega Valladolid Spain

    Sponsors and Collaborators

    • Fresenius Kabi
    • B. Braun Melsungen AG
    • European Society of Anaesthesiology and Intensive Care

    Investigators

    • Study Chair: Wolfgang F. Buhre, Prof. Dr. med., Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fresenius Kabi
    ClinicalTrials.gov Identifier:
    NCT03278548
    Other Study ID Numbers:
    • HC-G-H-1504
    • HE06-024-CP4
    First Posted:
    Sep 11, 2017
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fresenius Kabi
    HES
    HES 130
    Hydroxyethyl starch
    Additional relevant MeSH terms:
    Hypovolemia

    Study Results

    No Results Posted as of May 24, 2022