VolulyteTM in Cardiac Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
• Intervention / Treatment: Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM); Drug: Human serum albumin

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volulyte; 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); 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
Active Comparator: Human serum albumin; Human serum albumin (HSA 50g/L)	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Calculated red blood cell loss	up to 3rd postoperative day

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: David C Mazer, St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 14, 2012

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: VOLU-010-C P4