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

NCT ID: NCT01418521

Last Updated: 2011-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Elective Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ringer-albumin

Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery

Group Type: ACTIVE_COMPARATOR

Ringer- albumin

Intervention Type: DRUG

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

Tetraspan

patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery

Group Type: EXPERIMENTAL

Balanced hydroxyethyl starch solution

Intervention Type: DRUG

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

Interventions

Balanced hydroxyethyl starch solution

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

Intervention Type: DRUG

Ringer- albumin

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

Intervention Type: DRUG

Other Intervention Names

Tetraspan; HARTMANN Solution; Human albumin 20%- Zenalb

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Rambam Health Care Campus, cardiac surgery department

Principal Investigators

Zvi Adler, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam health care campus

Haifa, , Israel

Countries

Israel

Central Contacts

Liran Shani, MD

Role: CONTACT

l_shani@rambam.health.gov.il

972-8542631

Facility Contacts

Liran Shani, MD

Role: primary

l_shani@rambam.health.gov.il

Other Identifiers

RMB-0058.CTIL

Identifier Type: -

Identifier Source: org_study_id