Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02570464
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2015-10-02
Brief Title:
Aortic Cross-Clamping and Systemic Inflammatory Response in Humans Effect of Ischemic Preconditioning
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Aortic Cross-Clamping and Systemic Inflammatory Response in Humans Effect of Ischemic Preconditioning
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLARIS
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 IR 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 IR 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
Ischemic preconditioning first described in cardiac surgery is a mechanism whereby tissues exposed to a brief period of nonlethal IR 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None