The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
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
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
Calculated red blood cell loss
Time frame: up to 3rd postoperative day
Haemodynamics
Time frame: up to 3rd postoperative day
Fluid input/output
Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day
Time frame: up to 3rd postoperative day
Use of vasoactive and inotropic drugs
Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day
Time frame: up to 3rd postoperative day
Laboratory parameters
Serum creatinine concentration at day 28 after surgery
Time frame: up to day 28 after surgery
Laboratory parameters
set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day
Time frame: up to 3rd postoperative day
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Toronto General Hospital
Toronto, Ontario, Canada