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

NCT ID: NCT02570464

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Patients undergoing aortic aneurysm surgery with RIPC

Blood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery with Remote ischemic preconditioning (RIPC)

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: PROCEDURE

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

Blood drawn

Intervention Type: BIOLOGICAL

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

Patients undergoing aortic aneurysm surgery without RIPC

Blood drawn is done for patient undergoing elective open infrarenal abdominal aortic aneurysm repair surgery without Remote ischemic preconditioning (RIPC)

Group Type: SHAM_COMPARATOR

Blood drawn

Intervention Type: BIOLOGICAL

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

Interventions

Remote ischemic preconditioning

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

Intervention Type: PROCEDURE

Blood drawn

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Melody DUSSEAUX, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36645250 (View on PubMed)

Other Identifiers

2010/147/HP

Identifier Type: -

Identifier Source: org_study_id