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CompletedNCT00978588Updated Feb 3, 2012

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

An interventional study of 6% hydroxyethyl starch 130/0.4 and 5% albumin in Mitral Valvular Heart Disease, sponsored by Yonsei University. Completed. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Sex
All
01

Study summary

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

02

Conditions studied

  • Mitral Valvular Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Mitral valvular heart disease

Exclusion criteria

Exclusion Criteria:

  • Status of Infection
  • Re-operation
  • Liver failure
  • Renal disease
  • Administration of steroid
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    HES 130/0.4

    Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin

  • Active comparator
    5% albumin

    Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin

Interventions

  • Drug6% 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

06

What researchers measure

Primary outcomes

  1. the pure effect of priming solutions

    Time frame: after CPB

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00978588
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 17, 2009
Start date
Feb 2008
Primary completion
Dec 2008
Completion
Aug 2009
Last update
Feb 3, 2012

Study contacts

Young Lan Kwak, M.D.,PhD,
principal investigator · Severance Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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