Clinical trial NCT01418521: Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery
Official title: Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Elective Cardiac Surgery
Keywords: Cardiac surgery
Balanced 3rd generation Hydroxyethyl starch
Tetraspan
Ringer-albumin
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.


Eligibility criteria: 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.

Primary outcomes:
measure: Chest tube drainage volume
timeFrame: Total volume at the time of removal of drains (48 hours after surgery on average)
Secondary outcomes:
measure: Volume of replacement fluids given after surgery at each group
timeFrame: Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)
measure: In hospital - all cause mortality
timeFrame: End of hospitalization (5 days postsurgery on average)
measure: 30-days all cause mortality
timeFrame: 30 days from surgery
measure: Incidence of kidney injury as defined by RIFLE criteria
timeFrame: Duration of hospitalization after surgery (expected average duration of 5 days)
measure: Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.
timeFrame: Duration of hospitalization after surgery (expected average duration of 5 days)
measure: Volume of Transfused blood products during hospitalization postsurgery
timeFrame: Duration of hospitalization after surgery (expected average duration of 5 days)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Zvi Adler, MD
role: PRINCIPAL_INVESTIGATOR
References: