VolulyteTM in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT01553617
First received: March 7, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.


Condition Intervention Phase
Heart; Dysfunction Postoperative, Cardiac Surgery
Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Drug: Human serum albumin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Calculated red blood cell loss [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Haemodynamics [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]
  • Fluid input/output [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]
    Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day

  • Use of vasoactive and inotropic drugs [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]
    Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day

  • Laboratory parameters [ Time Frame: up to day 28 after surgery ] [ Designated as safety issue: Yes ]
    Serum creatinine concentration at day 28 after surgery

  • Laboratory parameters [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: Yes ]
    set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day


Enrollment: 133
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volulyte
6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
Active Comparator: Human serum albumin
Human serum albumin (HSA 50g/L)
Drug: Human serum albumin
Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female adult patients
  • undergoing primary elective cardiac surgery applying extracorporeal circulation
  • signed written informed consent

Exclusion Criteria:

  • known contraindication against scheduled medication
  • pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
  • planned systemic hypothermia (body temperature < 30°C)
  • expected time on ECC ≥ 2 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553617

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: David C Mazer St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
  More Information

No publications provided

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT01553617     History of Changes
Other Study ID Numbers: VOLU-010-C P4
Study First Received: March 7, 2012
Last Updated: June 25, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Albunex
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on July 31, 2014