Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.

Official Title
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Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery

Conditions
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Elective Cardiac Surgery

Intervention / Treatment
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* Drug: Balanced hydroxyethyl starch solution
* Drug: Ringer- albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed. Male or Female subject, 18 years or older. Any elective cardiac surgery Exclusion Criteria: Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L. Hyperhydration states (e.g. pulmonary edema, congestive heart failure). Renal failure with creatinine blood levels > 2.5 mg/dL or eGFR < 30 ml/min (calculated using the DMRD formula). Oliguria (UO<0.5ml\kg\hr) or anuria (not related to hypovolemia) more than 12 hours. Current Intracranial hemorrhage. Current, hard to balance hyperkalemia. Severe hypernatremia or severe hyperchloremia. Known hypersensitivity to hydroxyethyl starch or to any of the excipients.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ringer-albumin<br>Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery | Drug: Ringer- albumin<br>* Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery<br>* Other names: Human albumin 20%- Zenalb;|
| Experimental: Tetraspan<br>patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery | Drug: Balanced hydroxyethyl starch solution<br>* Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.<br>* Other names: Tetraspan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube drainage volume |  | Total volume at the time of removal of drains (48 hours after surgery on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of replacement fluids given after surgery at each group |  | Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average) | 
| In hospital - all cause mortality |  | End of hospitalization (5 days postsurgery on average) | 
| 30-days all cause mortality |  | 30 days from surgery | 
| Incidence of kidney injury as defined by RIFLE criteria |  | Duration of hospitalization after surgery (expected average duration of 5 days) | 
| Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization. |  | Duration of hospitalization after surgery (expected average duration of 5 days) | 
| Volume of Transfused blood products during hospitalization postsurgery |  | Duration of hospitalization after surgery (expected average duration of 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Balanced 3rd generation Hydroxyethyl starch, Tetraspan, Ringer-albumin