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
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
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
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
Learn more about this trial
Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair
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