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

Rambam Health Care Campus300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Elective Cardiac Surgery

Interventions

Balanced hydroxyethyl starch solutionDRUG

Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.

Ringer- albuminDRUG

Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Rambam health care campus

Haifa, Israel

Outcomes

Primary Outcomes

Chest tube drainage volume

Time frame: Total volume at the time of removal of drains (48 hours after surgery on average)

Secondary Outcomes

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)

In hospital - all cause mortality

Time frame: End of hospitalization (5 days postsurgery on average)

30-days all cause mortality

Time frame: 30 days from surgery

Incidence of kidney injury as defined by RIFLE criteria

Time frame: Duration of hospitalization after surgery (expected average duration of 5 days)

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)

Volume of Transfused blood products during hospitalization postsurgery

Time frame: Duration of hospitalization after surgery (expected average duration of 5 days)

Central Contacts

Liran Shani, MD

CONTACT

972-8542631 l_shani@rambam.health.gov.il

Data from ClinicalTrials.gov

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