VolulyteTM in Cardiac Surgery

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553617
• Other study ID #: VOLU-010-C P4
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2012
• Last updated: June 25, 2014
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

Drug:
• 6% 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
• Human serum albumin
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

Locations

Country	Name	City	State
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	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated red blood cell loss		up to 3rd postoperative day	Yes
Secondary	Haemodynamics		up to 3rd postoperative day	No
Secondary	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	No
Secondary	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	No
Secondary	Laboratory parameters	Serum creatinine concentration at day 28 after surgery	up to day 28 after surgery	Yes
Secondary	Laboratory parameters	set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day	up to 3rd postoperative day	Yes