Congenital Heart DiseaseNCT01479049
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
A study testing MP (moderate potassium) group and HP (High potassium) group in people with Congenital Heart Disease, run by Xijing Hospital at 1 site in China.
Trial summary
The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- MP (moderate potassium) group and HP (High potassium) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Oct 2010
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients (body weight<10 kg)
- congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.
Who cannot join
- other systemic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032
About this study
Official title: The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial
The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.
- Conditions
- Congenital Heart Disease
- Being tested
- MP (moderate potassium) group, HP (High potassium) group
- Keywords
- congenital heart disease, cardiac surgery, cardiopulmonary bypass, cardioplegia
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP (moderate potassium) groupDrug
Also called moderate potassium cardioplegia
Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation
HP (High potassium) groupDrug
Also called High potassium cardioplegia
Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.
| Study group | Role | What they receive |
|---|---|---|
| MP group | Experimental | Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery. Receives: Drug: MP (moderate potassium) group |
| HP group | Active comparator | Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation Receives: Drug: HP (High potassium) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative Serum cTnI concentration decreased significantly in 24hours
myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.
Measured: 24h after myocardial reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenxiao Jin, PhD, Principal investigator, Department of Cardiovascular Surgery, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479049
- Sponsor's protocol ID
- XJXZ2009-1010
- Status last verified
- Nov 2011
- First submitted
- 7 Oct 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01479049
- Acronym / sponsor ID
- XJXZ2009-1010
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, cardiac surgery, cardiopulmonary bypass, cardioplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Nov 2011 (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.
The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP group | Experimental | Drug: MP (moderate potassium) groupHearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery. |
| HP group | Active comparator | Drug: HP (High potassium) groupHearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patients (body weight<10 kg)
- congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.
Key exclusion criteria (1 listed)
- other systemic diseases
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 |
|---|---|---|
| MP (moderate potassium) groupAlso: moderate potassium cardioplegiaHearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation | Drug | MP group |
| HP (High potassium) groupAlso: High potassium cardioplegiaHearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation. | Drug | HP group |
Primary outcome
post-operative Serum cTnI concentration decreased significantly in 24hours
Time frame: 24h after myocardial reperfusion
myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.
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 24 Nov 2011.
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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.
Zhenxiao Jin, PhD principal investigator
Department of Cardiovascular Surgery, Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MP (moderate potassium) group and HP (High potassium) group in people with Congenital Heart Disease, run by Xijing Hospital at 1 site in China.
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 2 inclusion and 1 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 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
post-operative Serum cTnI concentration decreased significantly in 24hours (time frame: 24h after myocardial reperfusion). 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 24 Nov 2011.