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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01418521 |
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Date of registration:
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09/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery
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Scientific 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 |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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300 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01418521 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Liran Shani, MD |
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Address:
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Telephone:
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972-8542631 |
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Email:
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l_shani@rambam.health.gov.il |
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Affiliation:
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Name:
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Liran Shani, MD |
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Address:
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Telephone:
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Email:
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l_shani@rambam.health.gov.il |
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Affiliation:
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Name:
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Zvi Adler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Elective Cardiac Surgery
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Intervention(s)
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Drug: Balanced hydroxyethyl starch solution
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Drug: Ringer- albumin
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Primary Outcome(s)
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Chest tube drainage volume
[Time Frame: Total volume at the time of removal of drains (48 hours after surgery on average)]
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Secondary Outcome(s)
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Incidence of kidney injury as defined by RIFLE criteria
[Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days)]
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Volume of Transfused blood products during hospitalization postsurgery
[Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days)]
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Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.
[Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days)]
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In hospital - all cause mortality
[Time Frame: End of hospitalization (5 days postsurgery on average)]
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Volume of replacement fluids given after surgery at each group
[Time Frame: Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)]
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30-days all cause mortality
[Time Frame: 30 days from surgery]
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Secondary ID(s)
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RMB-0058.CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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