Clinical trial NCT01174719: Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
Official title: Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Valvular Heart Disease
Coronary Artery Disease
Keywords: Hydroxyethylstarch
Humanalbumin
Ringer Lactate
patients undergoing cardiac surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Valve replacement
* Coronary bypass surgery

Exclusion Criteria:

* Severe left ventricular dysfunction
* Coagulation disorders

Primary outcomes:
measure: chest tube drainage
timeFrame: 24 hours
Secondary outcomes:
measure: Hemoglobin concentration
timeFrame: induction of anesthesia = baseline
measure: Hematocrit value
timeFrame: induction of anesthesia = baseline
measure: platelet count
timeFrame: induction of anesthesia = baseline
measure: activated clotting time
timeFrame: induction of anesthesia = baseline
measure: Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
timeFrame: induction of anethesia = baseline
measure: Hemoglobin concentration
timeFrame: average 1 hour on cardiopulmonary bypass
measure: Hematocrit value
timeFrame: average 1 hour on cardiopulmonary bypass
measure: Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
timeFrame: average 1 hour on cardiopulmonary bypass
measure: activated clotting time
timeFrame: average 1 hour on cardiopulmonary bypass
measure: Hemoglobin concentration
timeFrame: 30 minutes after arrival ICU
measure: Hematocrit value
timeFrame: 30 minutes after arrival ICU
measure: platelet count
timeFrame: 30 minutes after arrival ICU
measure: activated clotting time
timeFrame: 30 minutes after arrival ICU
measure: Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
timeFrame: 30 minutes after arrival ICU
measure: Hemoglobin concentration
timeFrame: 24 hours after surgery
measure: Hematocrit value
timeFrame: 24 hours after surgery
measure: platelet count
timeFrame: 24 hrs after surgery
measure: Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
timeFrame: 24 hrs after surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital
Study officials:
affiliation: Medical University of Vienna
name: Eva M Base, MD
role: PRINCIPAL_INVESTIGATOR
References: