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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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 Type

Interventional

Primary Outcome

Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair

Condition

Abdominal Aortic Aneurysm

Intervention

Limb remote ischemic preconditioning(LRIP)

Study Arms / Comparison Groups

 Limb RIPC
Description:  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.

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 <60mmHg)

          -  history of inflammatory bowel disease

          -  history of diarrhea (≥2 liquid stools per day for ≥2 days) within 1 week of surgery

          -  intestinal chronic inflammatory disease

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Ke-Xuan Liu, Ph.D, ,

Administrative Informations

NCT ID

NCT01344239

Organization ID

LRIP701126

Secondary IDs

CLi

Responsible Party

Sponsor-Investigator

Study Sponsor

Cai Li

Study Sponsor

Ke-Xuan Liu, Ph.D, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University

Verification Date

May 2013