Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva M. Base, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01174719
First received: August 2, 2010
Last updated: April 6, 2015
Last verified: April 2015

August 2, 2010
April 6, 2015
March 2006
February 2010   (final data collection date for primary outcome measure)
chest tube drainage [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01174719 on ClinicalTrials.gov Archive Site
  • Hemoglobin concentration [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • activated clotting time [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: induction of anethesia = baseline ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • Hemoglobin concentration [ Time Frame: average 1 hour on cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: average 1 hour on cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: average 1 hour on cardiopulmonary bypass ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • activated clotting time [ Time Frame: average 1 hour on cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Hemoglobin concentration [ Time Frame: 30 minutes after arrival ICU ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: 30 minutes after arrival ICU ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: 30 minutes after arrival ICU ] [ Designated as safety issue: No ]
  • activated clotting time [ Time Frame: 30 minutes after arrival ICU ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: 30 minutes after arrival ICU ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • Hemoglobin concentration [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: 24 hrs after surgery ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: 24 hrs after surgery ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • Hemoglobin concentration [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • activated clotting time [ Time Frame: induction of anesthesia = baseline ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: induction of anethesia = baseline ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • Hemoglobin concentration [ Time Frame: during cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: during cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: during cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: during cardiopulmonary bypass ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • activated clotting time [ Time Frame: during cardiopulmonary bypass ] [ Designated as safety issue: No ]
  • Hemoglobin concentration [ Time Frame: arrival ICU ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: arrival ICU ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: arrival ICU ] [ Designated as safety issue: No ]
  • activated clotting time [ Time Frame: arrival ICU ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: arrival ICU ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
  • Hemoglobin concentration [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • Hematocrit value [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: 24 hrs after surgery ] [ Designated as safety issue: No ]
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) [ Time Frame: 24 hrs after surgery ] [ Designated as safety issue: No ]
    using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Not Provided
Not Provided
 
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Valvular Heart Disease
  • Coronary Artery Disease
  • Drug: volume replacement
    Hydroxyethylstarch up to 50mL/kg/24 hrs
    Other Names:
    • Voluven
    • HES 130/0.4
  • Drug: Humanalbumin 5%
    Humanalbumin 5% up to 50 mL/kg/24 hours
    Other Name: Humanalbumin 5% Baxter
  • Drug: volume replacement
    up 10 50mL/kg/24 hours
  • Active Comparator: Hydroxyethylstarch
    Intervention: Drug: volume replacement
  • Active Comparator: Humanalbumin
    Intervention: Drug: Humanalbumin 5%
  • Active Comparator: Ringer lactate
    Intervention: Drug: volume replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Valve replacement
  • Coronary bypass surgery

Exclusion Criteria:

  • Severe left ventricular dysfunction
  • Coagulation disorders
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01174719
HAHes
Yes
Eva M. Base, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Eva M Base, MD Medical University of Vienna
Medical University of Vienna
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP