VolulyteTM in Cardiac Surgery
Phase 4
Completed
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery
- Interventions
- Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
- Registration Number
- NCT01553617
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Volulyte 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) Human serum albumin Human serum albumin Human serum albumin (HSA 50g/L)
- Primary Outcome Measures
Name Time Method Calculated red blood cell loss up to 3rd postoperative day
- Secondary Outcome Measures
Name Time Method 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 3rd postoperative day set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day
Trial Locations
- Locations (5)
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada