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Completed

NCT Number: NCT01174719

Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).

Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even less expensive and as safe alternative has to be shown.

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Key information

Conditions

Valvular Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vienna General Hospital

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Valve replacement
  • Coronary bypass surgery

Exclusion criteria

  • Severe left ventricular dysfunction
  • Coagulation disorders

Treatment and study plan

volume replacement

Drug

Hydroxyethylstarch up to 50mL/kg/24 hrs

Other names: Voluven, HES 130/0.4

Humanalbumin 5%

Drug

Humanalbumin 5% up to 50 mL/kg/24 hours

Other names: Humanalbumin 5% Baxter

Primary outcomes

  1. chest tube drainage

    Time frame: 24 hours

Secondary outcomes

  1. Hemoglobin concentration

    Time frame: induction of anesthesia = baseline

  2. Hematocrit value

    Time frame: induction of anesthesia = baseline

  3. platelet count

    Time frame: induction of anesthesia = baseline

  4. activated clotting time

    Time frame: induction of anesthesia = baseline

  5. Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)

    Time frame: induction of anethesia = baseline

    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)

  6. Hemoglobin concentration

    Time frame: average 1 hour on cardiopulmonary bypass

  7. Hematocrit value

    Time frame: average 1 hour on cardiopulmonary bypass

  8. Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)

    Time frame: average 1 hour on cardiopulmonary bypass

    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)

  9. activated clotting time

    Time frame: average 1 hour on cardiopulmonary bypass

  10. Hemoglobin concentration

    Time frame: 30 minutes after arrival ICU

  11. Hematocrit value

    Time frame: 30 minutes after arrival ICU

  12. platelet count

    Time frame: 30 minutes after arrival ICU

  13. activated clotting time

    Time frame: 30 minutes after arrival ICU

  14. Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)

    Time frame: 30 minutes after arrival ICU

    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)

  15. Hemoglobin concentration

    Time frame: 24 hours after surgery

  16. Hematocrit value

    Time frame: 24 hours after surgery

  17. platelet count

    Time frame: 24 hrs after surgery

  18. Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)

    Time frame: 24 hrs after surgery

    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 4, 2010
Registry last updated
Apr 8, 2015

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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