A Phase 4 interventional study of 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) and Human serum albumin in Heart; Dysfunction Postoperative, Cardiac Surgery, sponsored by Fresenius Kabi. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Fresenius Kabi · Phase 4, Interventional, and Treatment
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Fresenius Kabi is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Human serum albumin (HSA 50g/L)
Drug: Human serum albumin
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
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
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Fresenius Kabi