NCT01344239

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

April 26, 2011

Last Update Submit

May 11, 2013

Conditions

Abdominal Aortic Aneurysm

Keywords

aortic aneurysmischemia/reperfusionpreconditioningpulmonary injuryintestinal injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Limb RIPC

EXPERIMENTAL

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)

convention

NO INTERVENTION

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

Interventions

Limb remote ischemic preconditioning(LRIP)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.

Also known as: LRIP
Limb RIPC

Eligibility Criteria

Age20 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
  • 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

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.

    PMID: 36645250DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAortic AneurysmIschemiaLung Injury

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Ke-Xuan Liu, Ph.D

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University, Department of Anesthesiology,First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 29, 2011

Study Start

January 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

May 14, 2013

Record last verified: 2013-05