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

Phase 4

• Conditions: Elective Cardiac Surgery
• Interventions: Drug: Ringer- albumin; Drug: Balanced hydroxyethyl starch solution

• Registration Number: NCT01418521
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-16
• Last Update Submitted: 2011-08-16
• Study First Posted: 2011-08-17
• Last Update Posted: 2011-08-17
• Primary Completion: 2013-07
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer-albumin	Ringer- albumin	Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery
Tetraspan	Balanced hydroxyethyl starch solution	patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery

Primary Outcome Measures

Name	Time	Method
Chest tube drainage volume	Total volume at the time of removal of drains (48 hours after surgery on average)

Secondary Outcome Measures

Name	Time	Method
Volume of replacement fluids given after surgery at each group	Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)
In hospital - all cause mortality	End of hospitalization (5 days postsurgery on average)
30-days all cause mortality	30 days from surgery
Incidence of kidney injury as defined by RIFLE criteria	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.	Duration of hospitalization after surgery (expected average duration of 5 days)
Volume of Transfused blood products during hospitalization postsurgery	Duration of hospitalization after surgery (expected average duration of 5 days)

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel