Status:
UNKNOWN
Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Elective Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01418521
Start Date
August 1 2011
End Date
August 1 2013
Last Update
August 17 2011
Active Locations (1)
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1
Rambam health care campus
Haifa, Israel