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

Elective Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01418521
• Other study ID #: RMB-0058.CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: August 16, 2011
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2011
• Source: Rambam Health Care Campus
• Contact: Liran Shani, MD
• Phone: 972-8542631
• Email: l_shani[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Cardiac Surgery

Intervention

Drug:
• Balanced hydroxyethyl starch solution
Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
• Ringer- albumin
Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest tube drainage volume		Total volume at the time of removal of drains (48 hours after surgery on average)	Yes
Secondary	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)	No
Secondary	In hospital - all cause mortality		End of hospitalization (5 days postsurgery on average)	Yes
Secondary	30-days all cause mortality		30 days from surgery	Yes
Secondary	Incidence of kidney injury as defined by RIFLE criteria		Duration of hospitalization after surgery (expected average duration of 5 days)	Yes
Secondary	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)	Yes
Secondary	Volume of Transfused blood products during hospitalization postsurgery		Duration of hospitalization after surgery (expected average duration of 5 days)	Yes