ClinicalTrials.gov
ClinicalTrials.gov Menu

VolulyteTM in Cardiac Surgery

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: NCT01553617
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Calculated red blood cell loss [ Time Frame: up to 3rd postoperative day ]

Secondary Outcome Measures :
  1. Haemodynamics [ Time Frame: up to 3rd postoperative day ]
  2. Fluid input/output [ Time Frame: up to 3rd postoperative day ]
    Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day

  3. Use of vasoactive and inotropic drugs [ Time Frame: up to 3rd postoperative day ]
    Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day

  4. Laboratory parameters [ Time Frame: up to day 28 after surgery ]
    Serum creatinine concentration at day 28 after surgery

  5. Laboratory parameters [ Time Frame: up to 3rd postoperative day ]
    set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General 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

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT01553617     History of Changes
Other Study ID Numbers: VOLU-010-C P4
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Pharmaceutical Solutions
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes