VolulyteTM in Cardiac Surgery

Study Overview
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Brief Summary
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The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.

Official Title
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Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients

Conditions
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Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention / Treatment
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* Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
* Drug: Human serum albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female adult patients undergoing primary elective cardiac surgery applying extracorporeal circulation signed written informed consent Exclusion Criteria: known contraindication against scheduled medication pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation planned systemic hypothermia (body temperature < 30°C) expected time on ECC ≥ 2 hours

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volulyte<br>6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) | Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)<br>* Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day<br>|
| Active Comparator: Human serum albumin<br>Human serum albumin (HSA 50g/L) | Drug: Human serum albumin<br>* Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated red blood cell loss |  | up to 3rd postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamics |  | up to 3rd postoperative day | 
| Fluid input/output | Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day | up to 3rd postoperative day | 
| Use of vasoactive and inotropic drugs | Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day | up to 3rd postoperative day | 
| Laboratory parameters | Serum creatinine concentration at day 28 after surgery | up to day 28 after surgery | 
| Laboratory parameters | set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day | up to 3rd postoperative day |