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

Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery

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 Overview

• Status: Unknown
• Conditions: Elective Cardiac Surgery
• Intervention / Treatment: Drug: Ringer- albumin; Drug: Balanced hydroxyethyl starch solution

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ringer-albumin; Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery	Drug: Ringer- albumin; Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery; Other Names: HARTMANN Solution; Human albumin 20%- Zenalb
EXPERIMENTAL: Tetraspan; patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery	Drug: Balanced hydroxyethyl starch solution; Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.; Other Names: Tetraspan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Zvi Adler, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2013
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (ESTIMATE): August 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2011
• Last Update Submitted That Met QC Criteria: August 16, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Cardiac surgery; Balanced 3rd generation Hydroxyethyl starch; Tetraspan; Ringer-albumin
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: RMB-0058.CTIL