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Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning

Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02570464
Acronym
CLARIS
Enrollment
68
Registered
2015-10-07
Start date
2012-03-31
Completion date
2015-12-31
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm

Brief 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 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.

Interventions

PROCEDURERemote ischemic preconditioning

Remote ischemic preconditioning is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair

BIOLOGICALBlood drawn

Blood drawn is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective open infrarenal abdominal aortic aneurysm repair * Scheduled surgery * Patients aged 30-85 years old

Exclusion criteria

* 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 * Surgery requiring subphrenic aortic cross-clamping * Emergency surgery * Patients taking sulfonylureas or Nicorandil * Patients having contraindication to clamp iliac arteries * Dementia

Design outcomes

Primary

MeasureTime frameDescription
Blood TNF-alpha rate24 hours post-surgeryBlood TNF-alpha rate is measured after reperfusion

Secondary

MeasureTime frameDescription
Blood I-CAM protein rate24 hours post-surgeryBlood I-CAM protein rate is measured after reperfusion
Blood Interleukines 1 rate24 hours post-surgeryBlood Interleukines 1 rate is measured after reperfusion
Blood lactates rate24 hours post-surgeryBlood lactates rate is measured after reperfusion
Blood Interleukines 6 rate24 hours post-surgeryBlood Interleukines 1 rate is measured after reperfusion
Blood Interleukines 10 rate24 hours post-surgeryBlood Interleukines 10 rate is measured after reperfusion
Blood Interleukines 4 rate24 hours post-surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026