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

NCT ID: NCT01344239

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-06-30

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Limb remote ischemic preconditioning(LRIP)

Intervention Type: PROCEDURE

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.

convention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

LRIP

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cai Li

OTHER

Sponsor Role: lead

Responsible Party

Cai Li

Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University, Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ke-Xuan Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

References

Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type: DERIVED

PMID: 36645250 (View on PubMed)

Other Identifiers

CLi

Identifier Type: REGISTRY

Identifier Source: secondary_id

LRIP701126

Identifier Type: -

Identifier Source: org_study_id