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VolulyteTM in Cardiac Surgery

Information source: Fresenius Kabi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) (Drug); Human serum albumin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fresenius Kabi

Official(s) and/or principal investigator(s):
David C Mazer, Principal Investigator, Affiliation: St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada


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

Clinical Details

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

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

Primary outcome: Calculated red blood cell loss

Secondary outcome:


Fluid input/output

Use of vasoactive and inotropic drugs

Laboratory parameters

Laboratory parameters


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- planned systemic hypothermia (body temperature < 30°C)

- expected time on ECC ≥ 2 hours

Locations and Contacts

Vancouver General Hospital, Vancouver, British Columbia, 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

Additional Information

Starting date: October 2012
Last updated: June 25, 2014

Page last updated: August 23, 2015

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