The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter
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| First Received Date ICMJE | September 15, 2010 | ||||
| Last Updated Date | August 19, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the neurological injury markers, including serum level of S-100B and NSE [ Time Frame: before surgery, 6h, 24h, 48h, and 72h after bypass ] [ Designated as safety issue: No ] the biomarkers of brain injury |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01231789 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
mini-mental state examination scale [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ] the neurological function |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter | ||||
| Official Title ICMJE | The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter | ||||
| Brief Summary | The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery. |
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| Detailed Description | BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after cardiac surgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective cardiac surgery, a randomized trial will be performed in current study. DESIGNING 150 patients will be randomize assigned to cardiac surgery with RIPC or without RIPC (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points. EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury in cardiac surgery. CONCLUSIONS: In patients undergoing elective cardiac surgery, RIPC reduces the incidence of postoperative cerebral injury. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Cardiac Surgery Patients | ||||
| Intervention ICMJE |
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| Study Arm (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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01231789 | ||||
| Other Study ID Numbers ICMJE | RIPC-Cardiac-Neuroprotection | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Xijing Hospital | ||||
| Study Sponsor ICMJE | Xijing Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Xijing Hospital | ||||
| Verification Date | June 2009 | ||||
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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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