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VolulyteTM in Cardiac Surgery

NCT01553617 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2014-06-26

No results posted yet for this study

Summary

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

Conditions

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

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

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

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • David C Mazer · St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01553617 on ClinicalTrials.gov