Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volulyte | Experimental | 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) |
|
| Human serum albumin | Active Comparator | Human serum albumin (HSA 50g/L) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated red blood cell loss | up to 3rd postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamics | 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 | up to 3rd postoperative day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David C Mazer | St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | Canada | |||
| Queen Elizabeth II Health Sciences Centre |
Not provided
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Human serum albumin | Drug | 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 |
|
| Use of vasoactive and inotropic drugs | Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day | up to 3rd postoperative day |
| Laboratory parameters | Serum creatinine concentration at day 28 after surgery | up to day 28 after surgery |
| Laboratory parameters | set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day | up to 3rd postoperative day |
| Halifax |
| Nova Scotia |
| Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| D011134 |
| Polysaccharides |
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |