Aortic AneurysmCLARISNCT02570464
Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning
A study testing Remote ischemic preconditioning and Blood drawn in people with Aortic Aneurysm, run by University Hospital, Rouen at 1 site in France.
Trial summary
Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of reactive oxygen species (ROS) and inflammatory… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Remote ischemic preconditioning and Blood drawn
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective open infrarenal abdominal aortic aneurysm repair
- Scheduled surgery
- Patients aged 30-85 years old
Who cannot join
- Patients undergoing endovascular treatment for infrarenal abdominal aortic aneurysm
- Patients younger than 30 years and older than 85 years
- pregnant women or nursing mother
- Adult under guardianship
- Refusal to sign a consent
- Patients whose survival at 28 days is unlikely
Show all 11Show fewer
- Surgery requiring subphrenic aortic cross-clamping
- Emergency surgery
- Patients taking sulfonylureas or Nicorandil
- Patients having contraindication to clamp iliac arteries
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs, including heart, kidney, and lung.
Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult. Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains unclear.
Read more
The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by ischemia-reperfusion and thereby protect the remote organs.
A single-center, prospective, randomized, parallel-group controlled trial is conducted on patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained from each participant. The study protocol was reviewed and approved by the Research Ethics Committee of Rouen, France.
Patients are divided in two groups : the sham-operated control group underwent surgery without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion served as the RIPC stimulus, before prolonged ischemia.
Blood samples are collected for analysis at the following time points: before surgery (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10. Cardiac, renal and pulmonary functions are evaluated with usual biological markers and clinical monitoring until 28 days after surgery.
Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to study the impact of RIPC in humans. This biological approach would help to better understand the mechanisms underlying this technique.
- Conditions
- Aortic Aneurysm
- Being tested
- Remote ischemic preconditioning, Blood drawn
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Remote ischemic preconditioning is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair
Blood drawnBiological
Blood drawn is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing aortic aneurysm surgery with RIPC | Experimental | Blood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery with Remote ischemic preconditioning (RIPC) Receives: Procedure: Remote ischemic preconditioning; Biological: Blood drawn |
| Patients undergoing aortic aneurysm surgery without RIPC | Sham comparator | Blood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery without Remote ischemic preconditioning (RIPC) Receives: Biological: Blood drawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood TNF-alpha rate
Blood TNF-alpha rate is measured after reperfusion
Measured: 24 hours post-surgery
Secondary outcomes (6)
Blood lactates rate
Blood lactates rate is measured after reperfusion
Measured: 24 hours post-surgery
Blood I-CAM protein rate
Blood I-CAM protein rate is measured after reperfusion
Measured: 24 hours post-surgery
Blood Interleukines 1 rate
Blood Interleukines 1 rate is measured after reperfusion
Measured: 24 hours post-surgery
Blood Interleukines 4 rate
Measured: 24 hours post-surgery
Blood Interleukines 6 rate
Blood Interleukines 1 rate is measured after reperfusion
Measured: 24 hours post-surgery
Blood Interleukines 10 rate
Blood Interleukines 10 rate is measured after reperfusion
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
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 Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Melody DUSSEAUX, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570464
- Sponsor's protocol ID
- 2010/147/HP
- Acronym
- CLARIS
- Status last verified
- May 2016
- First submitted
- 2 Oct 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
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 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT02570464
- Acronym / sponsor ID
- CLARIS / 2010/147/HP
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2015 (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.
Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs, including heart, kidney, and lung.
Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult. Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains unclear.
The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by ischemia-reperfusion and thereby protect the remote organs.
A single-center, prospective, randomized, parallel-group controlled trial is conducted on patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained from each participant. The study protocol was reviewed and approved by the Research Ethics Committee of Rouen, France.
Patients are divided in two groups : the sham-operated control group underwent surgery without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion served as the RIPC stimulus, before prolonged ischemia.
Blood samples are collected for analysis at the following time points: before surgery (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10. Cardiac, renal and pulmonary functions are evaluated with usual biological markers and clinical monitoring until 28 days after surgery.
Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to study the impact of RIPC in humans. This biological approach would help to better understand the mechanisms underlying this technique.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing aortic aneurysm surgery with RIPC | Experimental | Procedure: Remote ischemic preconditioning, Biological: Blood drawnBlood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery with Remote ischemic preconditioning (RIPC) |
| Patients undergoing aortic aneurysm surgery without RIPC | Sham comparator | Biological: Blood drawnBlood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery without Remote ischemic preconditioning (RIPC) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective open infrarenal abdominal aortic aneurysm repair
- Scheduled surgery
- Patients aged 30-85 years old
Key exclusion criteria (11 listed)
- Patients undergoing endovascular treatment for infrarenal abdominal aortic aneurysm
- Patients younger than 30 years and older than 85 years
- pregnant women or nursing mother
- Adult under guardianship
- Refusal to sign a consent
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 |
|---|---|---|
| Remote ischemic preconditioningRemote ischemic preconditioning is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair | Procedure or surgery | Patients undergoing aortic aneurysm surgery with RIPC |
| Blood drawnBlood drawn is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair | Biological | Patients undergoing aortic aneurysm surgery with RIPC, Patients undergoing aortic aneurysm surgery without RIPC |
Primary outcome
Blood TNF-alpha rate
Time frame: 24 hours post-surgery
Blood TNF-alpha rate is measured after reperfusion
6 secondary outcomes
Blood lactates rate
Time frame: 24 hours post-surgery
Blood I-CAM protein rate
Time frame: 24 hours post-surgery
Blood Interleukines 1 rate
Time frame: 24 hours post-surgery
Blood Interleukines 4 rate
Time frame: 24 hours post-surgery
Blood Interleukines 6 rate
Time frame: 24 hours post-surgery
Blood Interleukines 10 rate
Time frame: 24 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- 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.
Marie-Melody DUSSEAUX, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning and Blood drawn in people with Aortic Aneurysm, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood TNF-alpha rate (time frame: 24 hours post-surgery). 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 NCT02570464, 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 12 May 2016.