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Completed

NCT Number: NCT01553617

VolulyteTM in Cardiac Surgery

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

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Key information

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)

Drug

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

Drug

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

Primary outcomes

  1. Calculated red blood cell loss

    Time frame: up to 3rd postoperative day

Secondary outcomes

  1. Haemodynamics

    Time frame: up to 3rd postoperative day

  2. Fluid input/output

    Time frame: up to 3rd postoperative day

    Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day

  3. Use of vasoactive and inotropic drugs

    Time frame: up to 3rd postoperative day

    Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day

  4. Laboratory parameters

    Time frame: up to day 28 after surgery

    Serum creatinine concentration at day 28 after surgery

  5. Laboratory parameters

    Time frame: up to 3rd postoperative day

    set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2012
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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