VolulyteTM in Cardiac Surgery
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
1 other identifier
interventional
133
1 country
5
Brief Summary
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2012
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 26, 2014
June 1, 2014
1.3 years
March 7, 2012
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Calculated red blood cell loss
up to 3rd postoperative day
Secondary Outcomes (5)
Haemodynamics
up to 3rd postoperative day
Fluid input/output
up to 3rd postoperative day
Use of vasoactive and inotropic drugs
up to 3rd postoperative day
Laboratory parameters
up to day 28 after surgery
Laboratory parameters
up to 3rd postoperative day
Study Arms (2)
Volulyte
EXPERIMENTAL6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Human serum albumin
ACTIVE COMPARATORHuman serum albumin (HSA 50g/L)
Interventions
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
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 Criteria
You may qualify if:
- male or female adult patients
- undergoing primary elective cardiac surgery applying extracorporeal circulation
- signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
Study Sites (5)
Vancouver General Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David C Mazer
St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 14, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 26, 2014
Record last verified: 2014-06