Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01174719
First received: August 2, 2010
Last updated: August 10, 2010
Last verified: August 2010
  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
Cardiac Surgery
Coronary Artery Bypass Surgery
Valve Replacement
Drug: volume replacement
Drug: Humanalbumin 5%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Medical University of Vienna:

Primary Outcome Measures:
  • chest tube drainage [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)


Enrollment: 240
Study Start Date: March 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Valve replacement
  • Coronary bypass surgery

Exclusion Criteria:

  • Severe left ventricular dysfunction
  • Coagulation disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eva Maria Base, Associate Professor, Department of Cardiothoracic Anesthesia
ClinicalTrials.gov Identifier: NCT01174719     History of Changes
Other Study ID Numbers: HAHes
Study First Received: August 2, 2010
Last Updated: August 10, 2010
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Hydroxyethylstarch
Humanalbumin
Ringer Lactate
patients undergoing cardiac surgery

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014