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

Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair:A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Procedure: Limb remote ischemic preconditioning(LRIP)

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
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Limb RIPC; 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.	Procedure: Limb remote ischemic preconditioning(LRIP); 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.; Other Names: LRIP
No Intervention: convention; Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	June,2011

Collaborators and Investigators

• Sponsor: Cai Li
• Investigators: Principal Investigator: Ke-Xuan Liu, Ph.D, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 11, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: aortic aneurysm; ischemia/reperfusion; preconditioning; pulmonary injury; intestinal injury
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Aortic Diseases; Aneurysm; Lung Injury; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: LRIP701126; CLi (CLi)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No