- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01910961
Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
July 26, 2013 updated by: Cai Li
Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cai Li, MD
- Phone Number: +86-18602017796
- Email: licaigz@yahoo.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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:
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hospitalization costs
Time Frame: 30 days after operation
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30 days after operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kexuan Liu, PhD, First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
July 26, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
July 30, 2013
Last Update Submitted That Met QC Criteria
July 26, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LRIP
- Liu Kexuan (Other Grant/Funding Number: from National Natural Science Foundation, Beijing, China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Aortic Aneurysm
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Assistance Publique - Hôpitaux de ParisUnknownSmall Abdominal Aortic Aneurysm | Abdominal Aortic Aneurysm,France
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Karolinska University HospitalEnrolling by invitationAneurysm | Aortic Aneurysm | Abdominal Aortic Aneurysm, Ruptured | Aneurysm Abdominal | Abdominal Aortic Aneurysm Without RuptureSweden
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EndologixActive, not recruiting1 Paravisceral Abdominal Aortic Aneurysm | 2 Juxtarenal Abdominal Aortic Aneurysm | 3 Pararenal Abdominal Aortic Aneurysm | 4 Complex Abdominal Aortic AneurysmsUnited States
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Medtronic CardiovascularCompletedAbdominal Aortic Aneurysms (AAA)United States
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Vascutek Ltd.TerminatedAbdominal Aortic Aneurysms (AAA)United Kingdom, Netherlands, Switzerland, Spain, Germany, Belgium, Sweden, Canada, France, Italy, Austria, Monaco
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Timothy Chuter, MDRecruitingThoracoabdominal Aortic Aneurysm | Paravisceral Abdominal Aortic AneurysmUnited States
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Washington University School of MedicineRecruitingAbdominal Aortic Aneurysm (AAA) | No Abdominal Aortic Aneurysm (Non-AAA)United States
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University of California, San DiegoRecruitingJuxtarenal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Pararenal Aortic Aneurysm | Complex Abdominal Aortic AneurysmUnited States
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Assistance Publique Hopitaux De MarseilleCompletedAbdominal Aortic AneurysmsFrance
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Hangzhou Endonom Medtech Co., Ltd.RecruitingJuxtarenal Abdominal Aortic AneurysmChina
Clinical Trials on limb RIPC
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Helsinki University Central HospitalAcademy of Finland; Finska Läkaresällskapet (funding); Helsinki University Hospital...Recruiting
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Oladipupo Olafiranye, MD, MSNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingContrast-induced Acute Kidney InjuryUnited States
-
Liverpool John Moores UniversityCompletedCardiovascular Disease RiskUnited Kingdom
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Westfälische Wilhelms-Universität MünsterRecruitingSepsis | Acute Kidney Injury | Critically IllGermany
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Seoul National University HospitalCompletedIschemic Reperfusion Injury | Radiotherapy | Other Reconstructive SurgeryKorea, Republic of
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Seoul National University HospitalCompletedRemote Ischemic PreconditioningKorea, Republic of
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Fundación Centro Nacional de Investigaciones Cardiovasculares...European CommissionRecruitingLymphoma | Anthracycline-induced Cardiac ToxicityNetherlands, Spain, Denmark, Germany, France, Portugal
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Shanghai Zhongshan HospitalCompletedCardiac SurgeryChina
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Changi General HospitalUniversity College Hospital GalwayCompletedContrast Induced Nephropathy | Remote Ischaemic PreconditioningSingapore
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Mid Western Regional Hospital, IrelandUnknownPeripheral Vascular DiseaseIreland