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
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedApril 8, 2015
April 1, 2015
3.9 years
August 2, 2010
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
chest tube drainage
24 hours
Secondary Outcomes (18)
Hemoglobin concentration
induction of anesthesia = baseline
Hematocrit value
induction of anesthesia = baseline
platelet count
induction of anesthesia = baseline
activated clotting time
induction of anesthesia = baseline
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
induction of anethesia = baseline
- +13 more secondary outcomes
Study Arms (3)
Hydroxyethylstarch
ACTIVE COMPARATORHumanalbumin
ACTIVE COMPARATORRinger lactate
ACTIVE COMPARATORInterventions
Hydroxyethylstarch up to 50mL/kg/24 hrs
Humanalbumin 5% up to 50 mL/kg/24 hours
Eligibility Criteria
You may qualify if:
- Valve replacement
- Coronary bypass surgery
You may not qualify if:
- Severe left ventricular dysfunction
- Coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna General Hospital
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva M Base, MD
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 4, 2010
Study Start
March 1, 2006
Primary Completion
February 1, 2010
Study Completion
April 1, 2010
Last Updated
April 8, 2015
Record last verified: 2015-04