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
About this trial
This is an interventional prevention trial for Abdominal Aortic Aneurysm
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)
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
NCT ID
NCT01910961
First Posted
June 27, 2013
Last Updated
July 26, 2013
Sponsor
Cai Li
Collaborators
Huazhong University of Science and Technology, West China Hospital
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
Learn more about this trial
Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
We'll reach out to this number within 24 hrs