VolulyteTM in Cardiac Surgery
Information source: Fresenius Kabi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart; Dysfunction Postoperative, Cardiac Surgery
Intervention: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) (Drug); Human serum albumin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Fresenius Kabi Official(s) and/or principal investigator(s): David C Mazer, Principal Investigator, Affiliation: St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
Summary
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective
open-heart surgery in adult patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Calculated red blood cell loss
Secondary outcome: HaemodynamicsFluid input/output Use of vasoactive and inotropic drugs Laboratory parameters Laboratory parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: October 2012
Last updated: June 25, 2014
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