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

NCT ID: NCT01910961

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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limb RIPC

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 RIPC

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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limb RIPC

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

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limb remote ischemic preconditioning

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Cai Li

OTHER

Sponsor Role lead

Responsible Party

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Cai Li

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kexuan Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Central Contacts

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Cai Li, MD

Role: CONTACT

+86-18602017796

References

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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

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Liu Kexuan

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LRIP

Identifier Type: -

Identifier Source: org_study_id

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