NCT01910961

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

June 27, 2013

Last Update Submit

July 26, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Secondary Outcomes (1)

  • hospitalization costs

    30 days after operation

Study Arms (2)

limb RIPC

EXPERIMENTAL

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 RIPC

convention

NO INTERVENTION

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.

Interventions

limb RIPCPROCEDURE

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

Also known as: limb remote ischemic preconditioning
limb RIPC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of abdominal aortic aneurysm
  • Must be received open abdominal aortic aneurysm repair

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Kexuan Liu, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 30, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

July 30, 2013

Record last verified: 2013-07