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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01418521
Recruitment Status : Unknown
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Rambam Health Care Campus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Elective Cardiac Surgery Drug: Balanced hydroxyethyl starch solution Drug: Ringer- albumin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Starch

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ringer-albumin
Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery
 Drug: Ringer- albumin
Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery
Other Names:
  • HARTMANN Solution
  • Human albumin 20%- Zenalb
Experimental: Tetraspan
patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery
 Drug: Balanced hydroxyethyl starch solution
Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
Other Name: Tetraspan


Outcome Measures
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Primary Outcome Measures :
  1. Chest tube drainage volume [ Time Frame: Total volume at the time of removal of drains (48 hours after surgery on average) ]

Secondary Outcome Measures :
  1. 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) ]
  2. In hospital - all cause mortality [ Time Frame: End of hospitalization (5 days postsurgery on average) ]
  3. 30-days all cause mortality [ Time Frame: 30 days from surgery ]
  4. Incidence of kidney injury as defined by RIFLE criteria [ Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days) ]
  5. 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) ]
  6. Volume of Transfused blood products during hospitalization postsurgery [ Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418521


Contacts
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Contact: Liran Shani, MD 972-8542631 l_shani@rambam.health.gov.il

Locations
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Israel
Rambam health care campus
Haifa, Israel
Contact: Liran Shani, MD       l_shani@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Zvi Adler, MD Rambam Health Care Campus
More Information
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Responsible Party: Zvi Adler, Rambam Health Care Campus, cardiac surgery department
ClinicalTrials.gov Identifier: NCT01418521    
Other Study ID Numbers: RMB-0058.CTIL
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: August 2011
Keywords provided by Rambam Health Care Campus:
Cardiac surgery
Balanced 3rd generation Hydroxyethyl starch
Tetraspan
Ringer-albumin
Additional relevant MeSH terms:
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Pharmaceutical Solutions