Abdominal Aortic AneurysmNCT01910961
Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
A study testing limb RIPC in people with Abdominal Aortic Aneurysm, run by Cai Li.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- limb RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of abdominal aortic aneurysm
- Must be received open abdominal aortic aneurysm repair
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- limb RIPC
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb RIPCProcedure or surgery
Also called limb remote ischemic preconditioning
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Secondary outcomes (1)
hospitalization costs
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Kexuan Liu, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910961
- Sponsor's protocol ID
- LRIP
- Other IDs
- Liu Kexuan
- Status last verified
- Jul 2013
- First submitted
- 27 Jun 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36645250
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01910961
- Acronym / sponsor ID
- LRIP
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Cai LiUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, West China Hospital
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| limb RIPC | Experimental | Procedure: limb RIPClimb 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of abdominal aortic aneurysm
- Must be received open abdominal aortic aneurysm repair
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| limb RIPCAlso: limb remote ischemic preconditioningLRIP 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 | Procedure or surgery | limb RIPC |
Primary outcome
all cause mortality
Time frame: one year
1 secondary outcome
hospitalization costs
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 36645250Liang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kexuan Liu, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing limb RIPC in people with Abdominal Aortic Aneurysm, run by Cai Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cai Li, MD (+86-18602017796, licaigz@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.