Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass

Mitral Valvular Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978588
• Other study ID #: 4-2007-0429
• Status: Completed
• Phase: N/A
• First received: September 16, 2009
• Last updated: February 2, 2012
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mitral valvular heart disease

Exclusion Criteria:

• Status of Infection

• Re-operation

• Liver failure

• Renal disease

• Administration of steroid

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases
• Mitral Valvular Heart Disease

Intervention

Drug:
• 6% hydroxyethyl starch 130/0.4 and 5% albumin
Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pure effect of priming solutions		after CPB	No