Heart; Dysfunction Postoperative, Cardiac Surgery
Conditions
Brief summary
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Interventions
DRUG6% 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
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
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated red blood cell loss | up to 3rd postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamics | up to 3rd postoperative day | — |
| Fluid input/output | up to 3rd postoperative day | Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day |
| Use of vasoactive and inotropic drugs | up to 3rd postoperative day | Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day |
| Laboratory parameters | up to day 28 after surgery | Serum creatinine concentration at day 28 after surgery |
Countries
Canada
Outcome results
None listed