- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174719
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Vienna General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Valve replacement
- Coronary bypass surgery
Exclusion Criteria:
- Severe left ventricular dysfunction
- Coagulation disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hydroxyethylstarch
|
Hydroxyethylstarch up to 50mL/kg/24 hrs
Other Names:
up 10 50mL/kg/24 hours
|
Active Comparator: Humanalbumin
|
Humanalbumin 5% up to 50 mL/kg/24 hours
Other Names:
|
Active Comparator: Ringer lactate
|
Hydroxyethylstarch up to 50mL/kg/24 hrs
Other Names:
up 10 50mL/kg/24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
chest tube drainage
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin concentration
Time Frame: induction of anesthesia = baseline
|
induction of anesthesia = baseline
|
|
Hematocrit value
Time Frame: induction of anesthesia = baseline
|
induction of anesthesia = baseline
|
|
platelet count
Time Frame: induction of anesthesia = baseline
|
induction of anesthesia = baseline
|
|
activated clotting time
Time Frame: induction of anesthesia = baseline
|
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)
|
induction of anethesia = baseline
|
Hemoglobin concentration
Time Frame: average 1 hour on cardiopulmonary bypass
|
average 1 hour on cardiopulmonary bypass
|
|
Hematocrit value
Time Frame: average 1 hour on cardiopulmonary bypass
|
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)
|
average 1 hour on cardiopulmonary bypass
|
activated clotting time
Time Frame: average 1 hour on cardiopulmonary bypass
|
average 1 hour on cardiopulmonary bypass
|
|
Hemoglobin concentration
Time Frame: 30 minutes after arrival ICU
|
30 minutes after arrival ICU
|
|
Hematocrit value
Time Frame: 30 minutes after arrival ICU
|
30 minutes after arrival ICU
|
|
platelet count
Time Frame: 30 minutes after arrival ICU
|
30 minutes after arrival ICU
|
|
activated clotting time
Time Frame: 30 minutes after arrival ICU
|
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)
|
30 minutes after arrival ICU
|
Hemoglobin concentration
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
|
Hematocrit value
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
|
platelet count
Time Frame: 24 hrs after surgery
|
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)
|
24 hrs after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva M Base, MD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAHes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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