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Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01174719
First Posted: August 4, 2010
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva M. Base, Medical University of Vienna
  Purpose

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.


Condition Intervention Phase
Valvular Heart Disease Coronary Artery Disease Drug: volume replacement Drug: Humanalbumin 5% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Eva M. Base, Medical University of Vienna:

Primary Outcome Measures:
  • chest tube drainage [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Hemoglobin concentration [ Time Frame: induction of anesthesia = baseline ]
  • Hematocrit value [ Time Frame: induction of anesthesia = baseline ]
  • platelet count [ Time Frame: induction of anesthesia = baseline ]
  • activated clotting time [ Time Frame: induction of anesthesia = baseline ]
  • 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)

  • Hemoglobin concentration [ Time Frame: average 1 hour on cardiopulmonary bypass ]
  • Hematocrit value [ Time Frame: average 1 hour on cardiopulmonary bypass ]
  • 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)

  • activated clotting time [ Time Frame: average 1 hour on cardiopulmonary bypass ]
  • Hemoglobin concentration [ Time Frame: 30 minutes after arrival ICU ]
  • Hematocrit value [ Time Frame: 30 minutes after arrival ICU ]
  • platelet count [ Time Frame: 30 minutes after arrival ICU ]
  • activated clotting time [ Time Frame: 30 minutes after arrival ICU ]
  • 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)

  • Hemoglobin concentration [ Time Frame: 24 hours after surgery ]
  • Hematocrit value [ Time Frame: 24 hours after surgery ]
  • platelet count [ Time Frame: 24 hrs after surgery ]
  • 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)


Enrollment: 240
Study Start Date: March 2006
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydroxyethylstarch Drug: volume replacement
Hydroxyethylstarch up to 50mL/kg/24 hrs
Other Names:
  • Voluven
  • HES 130/0.4
Active Comparator: Humanalbumin Drug: Humanalbumin 5%
Humanalbumin 5% up to 50 mL/kg/24 hours
Other Name: Humanalbumin 5% Baxter
Active Comparator: Ringer lactate Drug: volume replacement
up 10 50mL/kg/24 hours

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Valve replacement
  • Coronary bypass surgery

Exclusion Criteria:

  • Severe left ventricular dysfunction
  • Coagulation disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174719


Locations
Austria
Vienna General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Eva M Base, MD Medical University of Vienna
  More Information

Responsible Party: Eva M. Base, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01174719     History of Changes
Other Study ID Numbers: HAHes
First Submitted: August 2, 2010
First Posted: August 4, 2010
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Eva M. Base, Medical University of Vienna:
Hydroxyethylstarch
Humanalbumin
Ringer Lactate
patients undergoing cardiac surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes