Congenital Heart DefectsNCT01227096
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
An observational study of Congenital Heart Defects, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Electrical acupuncture stimulation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Jul 2011
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 2-12 years old children undergoing all types of open-heart surgery were included.
Who may be able to join
- Aged 2-12 years children undergoing repair of congenital heart defects without server pulmonary arterial hypertension or systematic disease.
- Get an informed consent from parental.
Who cannot join
- Patient's age is less than 2 years or more than 12 years.
- Patient with isolated atrial septal defect undergoing repair via thoracoscope completion.
- Patients with chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders.
- Patients without an informed consent from parental.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Natural Science Foundation of China
The purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects.
Read the detailed description
2-12 years old children undergoing repair of congenital heart defects were included, except for those with server pulmonary arterial hypertension, chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders were excluded. Children were equal randomized to EAPC(electroacupuncture preconditioning)or control group. Electroacupuncture was administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery in EAPC group. Control patients underwent sham placement of the electrode the arm without stimulation. The duration of cardiopulmonary bypass and aortic cross-clamp time was recorded. Myocardial injury was assessed by cardiac heart-type fatty acid-binding protein (HFAP) and cardiac troponin I (cTnI>0.40 ng/mL). 8-isoprostane , C-reactive protein, cytokines were measured pre- and postoperatively.
- Conditions
- Congenital Heart Defects
- Being tested
- Electrical acupuncture stimulation
- Keywords
- electroacupuncture pediatric cardioprotection
- 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.
Electrical acupuncture stimulationDevice
Also called Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture, Control | Not described Receives: Device: Electrical acupuncture stimulation | |
| Preconditioning, No preconditioning | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Investigators
- Xin-Li Ni, PhD, Principal investigator, Department of Anesthesiology of Xijing HospitalLi-Ze Xiong, PhD, Study chair, Xijing Hospital of Fouth Military Medical UniversityQiang Wang, PhD, Study director, Department of Anesthesiology of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227096
- Sponsor's protocol ID
- NSFC3090091-6
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Natural Science Foundation of China
- ClinicalTrials.gov ID
- NCT01227096
- Acronym / sponsor ID
- NSFC3090091-6
- Conditions
- Congenital Heart Defects
- Keywords
- electroacupuncture pediatric cardioprotection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 25 Oct 2010 (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 purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects.
Detailed description
2-12 years old children undergoing repair of congenital heart defects were included, except for those with server pulmonary arterial hypertension, chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders were excluded. Children were equal randomized to EAPC(electroacupuncture preconditioning)or control group. Electroacupuncture was administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery in EAPC group. Control patients underwent sham placement of the electrode the arm without stimulation. The duration of cardiopulmonary bypass and aortic cross-clamp time was recorded. Myocardial injury was assessed by cardiac heart-type fatty acid-binding protein (HFAP) and cardiac troponin I (cTnI>0.40 ng/mL). 8-isoprostane , C-reactive protein, cytokines were measured pre- and postoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture, Control | – | Device: Electrical acupuncture stimulation |
| Preconditioning, No preconditioning | – | – |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 2-12 years old children undergoing all types of open-heart surgery were included.
Key inclusion criteria (2 listed)
- Aged 2-12 years children undergoing repair of congenital heart defects without server pulmonary arterial hypertension or systematic disease.
- Get an informed consent from parental.
Key exclusion criteria (4 listed)
- Patient's age is less than 2 years or more than 12 years.
- Patient with isolated atrial septal defect undergoing repair via thoracoscope completion.
- Patients with chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders.
- Patients without an informed consent from parental.
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 |
|---|---|---|
| Electrical acupuncture stimulationAlso: Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, Chinaelectroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery. | Device | Electro-acupuncture, Control |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Xin-Li Ni, PhD principal investigator
Department of Anesthesiology of Xijing Hospital
Li-Ze Xiong, PhD study chair
Xijing Hospital of Fouth Military Medical University
Qiang Wang, PhD study director
Department of Anesthesiology of Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defects, run by Air Force Military Medical University, China 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 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 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?
Results are not available in the source record.
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.
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 23 Jun 2011.