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

NCT02570464 | Completed

• 1 other identifier: 2010/147/HP
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Blood TNF-alpha rate

  Blood TNF-alpha rate is measured after reperfusion

  24 hours post-surgery

Secondary Outcomes (6)

• Blood lactates rate

  24 hours post-surgery

• Blood I-CAM protein rate

  24 hours post-surgery

• Blood Interleukines 1 rate

  24 hours post-surgery

• Blood Interleukines 4 rate

  24 hours post-surgery

• Blood Interleukines 6 rate

  24 hours post-surgery

Study Arms (2)

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)

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)

Biological: Blood drawn

Interventions

Remote ischemic preconditioning PROCEDURE

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

Patients undergoing aortic aneurysm surgery with RIPC

Blood drawn BIOLOGICAL

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

Patients undergoing aortic aneurysm surgery with RIPC; Patients undergoing aortic aneurysm surgery without RIPC

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 36645250 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Marie-Melody DUSSEAUX, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 7, 2015
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

FR (1)