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Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair

Primary Purpose

Abdominal Aortic Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
limb RIPC
Sponsored by
Cai Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Aortic Aneurysm

Eligibility Criteria

18 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    limb RIPC

    convention

    Arm Description

    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.The control group had an uninflated cuff placed on the left upper arm for 30 min.

    Outcomes

    Primary Outcome Measures

    all cause mortality

    Secondary Outcome Measures

    hospitalization costs

    Full Information

    First Posted
    June 27, 2013
    Last Updated
    July 26, 2013
    Sponsor
    Cai Li
    Collaborators
    Huazhong University of Science and Technology, West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01910961
    Brief Title
    Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
    Official Title
    Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    August 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cai Li
    Collaborators
    Huazhong University of Science and Technology, West China Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality, hospitalization costs and quality of life in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.
    Detailed Description
    Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators have revealed that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.Few groups have investigated the long term influence of limb remote ischemic preconditioning.Therefore, the investigators evaluated the impact of limb remote ischemic preconditioning on mortality, hospitalization costs and quality of life during elective abdominal aortic aneurysm repair in a prospective, randomized, controlled, single blind setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    limb RIPC
    Arm Type
    Experimental
    Arm Description
    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.The control group had an uninflated cuff placed on the left upper arm for 30 min.
    Intervention Type
    Procedure
    Intervention Name(s)
    limb RIPC
    Other Intervention Name(s)
    limb remote ischemic preconditioning
    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
    all cause mortality
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    hospitalization costs
    Time Frame
    30 days after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cai Li, MD
    Phone
    +86-18602017796
    Email
    licaigz@yahoo.com.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kexuan Liu, PhD
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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