Mitral Valvular Heart DiseaseNCT00978588
Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass
A study testing 6% hydroxyethyl starch 130/0.4 and 5% albumin in people with Mitral Valvular Heart Disease, run by Yonsei University.
Trial summary
Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valvular Heart Disease
- What is being tested?
- 6% hydroxyethyl starch 130/0.4 and 5% albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mitral valvular heart disease
Who cannot join
- Status of Infection
- Re-operation
- Liver failure
- Renal disease
- Administration of steroid
About this study
Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass
- Conditions
- Mitral Valvular Heart Disease
- Being tested
- 6% hydroxyethyl starch 130/0.4 and 5% albumin
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% hydroxyethyl starch 130/0.4 and 5% albuminDrug
Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| HES 130/0.4 | Experimental | Not described Receives: Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin |
| 5% albumin | Active comparator | Not described Receives: Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pure effect of priming solutions
Measured: after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Lan Kwak, M.D.,PhD,, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978588
- Sponsor's protocol ID
- 4-2007-0429
- Status last verified
- Feb 2012
- First submitted
- 16 Sep 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00978588
- Acronym / sponsor ID
- 4-2007-0429
- Conditions
- Mitral Valvular Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES 130/0.4 | Experimental | Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin |
| 5% albumin | Active comparator | Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mitral valvular heart disease
Key exclusion criteria (5 listed)
- Status of Infection
- Re-operation
- Liver failure
- Renal disease
- Administration of steroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6% hydroxyethyl starch 130/0.4 and 5% albuminInjection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass | Drug | 5% albumin, HES 130/0.4 |
Primary outcome
the pure effect of priming solutions
Time frame: after CPB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
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Mitral Regurgitation (MR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Lan Kwak, M.D.,PhD, principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 6% hydroxyethyl starch 130/0.4 and 5% albumin in people with Mitral Valvular Heart Disease, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pure effect of priming solutions (time frame: after CPB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.