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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Limb remote ischemic preconditioning(LRIP)
Sponsored by
Cai Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Aortic Aneurysm focused on measuring aortic aneurysm, ischemia/reperfusion, preconditioning, pulmonary injury, intestinal injury

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Limb RIPC

    convention

    Arm 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.

    Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia

    Outcomes

    Primary Outcome Measures

    Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair
    Compared with the control group, patients in the LRIP group had significantly higher Cs and Cd , along with lower PA-aDO2 and RI at various phase (P<0.05). Serum concentration of IL-6,IL-8, TNF-ɑ and MDA in LRIP group were decreased significantly at postoperative time points compared with those in control group (P<0.05), but SOD was increased significantly at the same time (P<0.05). Patient's ventilator support time and duration of ICU stay in LRIP group were shorter than that in control group (P<0.05)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2011
    Last Updated
    May 11, 2013
    Sponsor
    Cai Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01344239
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cai Li

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm
    Keywords
    aortic aneurysm, ischemia/reperfusion, preconditioning, pulmonary injury, intestinal injury

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Limb RIPC
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    convention
    Arm Type
    No Intervention
    Arm Description
    Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    Limb remote ischemic preconditioning(LRIP)
    Other Intervention Name(s)
    LRIP
    Intervention Description
    LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
    Primary Outcome Measure Information:
    Title
    Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair
    Description
    Compared with the control group, patients in the LRIP group had significantly higher Cs and Cd , along with lower PA-aDO2 and RI at various phase (P<0.05). Serum concentration of IL-6,IL-8, TNF-ɑ and MDA in LRIP group were decreased significantly at postoperative time points compared with those in control group (P<0.05), but SOD was increased significantly at the same time (P<0.05). Patient's ventilator support time and duration of ICU stay in LRIP group were shorter than that in control group (P<0.05)
    Time Frame
    June,2011

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ke-Xuan Liu, Ph.D
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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