Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
Recruitment status was Active, not recruiting
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| First Received Date ICMJE | October 22, 2010 | ||||||||||||
| Last Updated Date | June 22, 2011 | ||||||||||||
| Start Date ICMJE | October 2010 | ||||||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT01227096 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery | ||||||||||||
| Official Title ICMJE | National Natural Science Foundation of China | ||||||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Retention: Samples Without DNA Description: blood serum |
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| Sampling Method | Probability Sample | ||||||||||||
| Study Population | 2-12 years old children undergoing all types of open-heart surgery were included. |
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| Condition ICMJE | Congenital Heart Defects | ||||||||||||
| Intervention ICMJE | Device: Electrical acupuncture stimulation
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.
Other Name: Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||
| Estimated Completion Date | July 2011 | ||||||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 2 Years to 12 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | China | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01227096 | ||||||||||||
| Other Study ID Numbers ICMJE | NSFC3090091-6 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Xiong Li-Ze, Xijing Hospital of Fourth Military Medical University | ||||||||||||
| Study Sponsor ICMJE | Fourth Military Medical University | ||||||||||||
| Collaborators ICMJE | National Natural Science Foundation of China | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Fourth Military Medical University | ||||||||||||
| Verification Date | October 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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