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Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

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Disease Information

Descriptive Information
Brief Title † Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair
Official Title † Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair:A Randomized Controlled Trial
Brief Summary To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.
Detailed Description Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio, alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity of intestinal and pulmonary injury was assessed with different scoring methods, respectively. Markers of oxidative stress and systemic inflammation were measured as well.
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary Outcome Measure † Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm
Intervention † ProcedureLimb remote ischemic preconditioning(LRIP)
Study Arms / Comparison Groups Limb RIPC The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff. convention Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 62
Start Date † January 2008
Completion Date June 2011
Primary Completion Date May 2011
Eligibility Criteria † Inclusion Criteria: - Clinical diagnosis of abdominal aortic aneurysm - Must be received open abdominal aortic aneurysm repair Exclusion Criteria: - age >80 years old - Acute coronary syndrome or myocardial infraction within - 3 months - Chronic obstructive pulmonary emphysema - angina pain within 48 hours of repair procedure - ejection fraction less than 40% - poor pulmonary function (PaO2
Gender Both
Ages 20 Years - 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT01344239
Organization ID LRIP701126
Secondary IDs †† CLi
Responsible Party Sponsor-Investigator
Study Sponsor † Cai Li
Collaborators ††
Investigators † Principal Investigator: Ke-Xuan Liu, Ph.D, First Affiliated Hospital, Sun Yat-Sen University
Information Provided By
Verification Date May 2013
First Received Date † April 26, 2011
Last Updated Date May 11, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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