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

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Elective Cardiac Surgery

Intervention: Balanced hydroxyethyl starch solution (Drug); Ringer- albumin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Rambam Health Care Campus

Official(s) and/or principal investigator(s):
Zvi Adler, MD, Principal Investigator, Affiliation: Rambam Health Care Campus

Overall contact:
Liran Shani, MD, Phone: 972-8542631, Email: l_shani@rambam.health.gov.il

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Chest tube drainage volume

Secondary outcome:

Volume of replacement fluids given after surgery at each group

In hospital - all cause mortality

30-days all cause mortality

Incidence of kidney injury as defined by RIFLE criteria

Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.

Volume of Transfused blood products during hospitalization postsurgery

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Liran Shani, MD, Phone: 972-8542631, Email: l_shani@rambam.health.gov.il

Rambam health care campus, Haifa, Israel; Not yet recruiting
Liran Shani, MD, Email: l_shani@rambam.health.gov.il
Additional Information

Starting date: August 2011
Last updated: August 16, 2011

Page last updated: August 23, 2015

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