Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery

Conditions
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Valvular Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Drug: volume replacement
* Drug: Humanalbumin 5%
* Drug: volume replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Valve replacement Coronary bypass surgery Exclusion Criteria: Severe left ventricular dysfunction Coagulation disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydroxyethylstarch<br> | Drug: volume replacement<br>* Hydroxyethylstarch up to 50mL/kg/24 hrs<br>* Other names: HES 130/0.4;|
| Active Comparator: Humanalbumin<br> | Drug: Humanalbumin 5%<br>* Humanalbumin 5% up to 50 mL/kg/24 hours<br>* Other names: Humanalbumin 5% Baxter;|
| Active Comparator: Ringer lactate<br> | Drug: volume replacement<br>* up 10 50mL/kg/24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest tube drainage |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM) | induction of anethesia = baseline | 
| Hemoglobin concentration |  | average 1 hour on cardiopulmonary bypass | 
| Hematocrit value |  | average 1 hour on cardiopulmonary bypass | 
| Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) | using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM) | average 1 hour on cardiopulmonary bypass | 
| activated clotting time |  | average 1 hour on cardiopulmonary bypass | 
| Hemoglobin concentration |  | 30 minutes after arrival ICU | 
| Hematocrit value |  | 30 minutes after arrival ICU | 
| platelet count |  | 30 minutes after arrival ICU | 
| activated clotting time |  | 30 minutes after arrival ICU | 
| Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) | using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM) | 30 minutes after arrival ICU | 
| Hemoglobin concentration |  | 24 hours after surgery | 
| Hematocrit value |  | 24 hours after surgery | 
| platelet count |  | 24 hrs after surgery | 
| Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany) | using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM) | 24 hrs after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery