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

Rambam Health Care Campus

Status and phase: Unknown; Phase 4

Conditions: Elective Cardiac Surgery

Treatments: Drug: Balanced hydroxyethyl starch solution; Drug: Ringer- albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01418521

RMB-0058.CTIL

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Ringer-albumin

Active Comparator group

Description:

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

Treatment:

Drug: Ringer- albumin

Tetraspan

Experimental group

Description:

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

Treatment:

Drug: Balanced hydroxyethyl starch solution