OSA as a Remote Ischemic Preconditioning in Vascular Surgery

NCT04630535 | Recruiting

• 1 other identifier: IIT/2019/25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia. Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia. The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.

Conditions

Obstructive Sleep Apnea; Vascular Aneurysm; Ischemia Reperfusion Injury

Keywords

remote preconditioning

Outcome Measures

Primary Outcomes (1)

• Change of I/R injury markers

  Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration

  T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day

Secondary Outcomes (1)

• post-operative complications

  up to 30 post-operative days

Study Arms (2)

Obstructive Sleep Apnea

Pacient with OSA (AHI≥5) undergoing aorto-bifemoral bypass

Procedure: aorto-bifemoral bypass surgery

Without Obstructive Sleep Apnea

Patinets without OSA undergoing aorto-bifemoral bypass

Procedure: aorto-bifemoral bypass surgery

Interventions

aorto-bifemoral bypass surgery PROCEDURE

aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)

Obstructive Sleep Apnea; Without Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)

You may qualify if:

• patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)

You may not qualify if:

• emergent surgery
• aorto-bifemoral bypass using deep vein graft
• re-operations
• known OSA with CPAP treatment

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Masaryk University: collaborator

Study Sites (1)

St. Anne's University Hospital Brno

Brno, Czech Republic, 65691, Czechia

RECRUITING

Related Publications (13)

• Katseni K, Chalkias A, Kotsis T, Dafnios N, Arapoglou V, Kaparos G, Logothetis E, Iacovidou N, Karvouni E, Katsenis K. The Effect of Perioperative Ischemia and Reperfusion on Multiorgan Dysfunction following Abdominal Aortic Aneurysm Repair. Biomed Res Int. 2015;2015:598980. doi: 10.1155/2015/598980. Epub 2015 Dec 21.

  PMID: 26798637 BACKGROUND

• Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.

  PMID: 3769170 BACKGROUND

• Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME. Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial. J Endovasc Ther. 2009 Dec;16(6):680-9. doi: 10.1583/09-2817.1.

  PMID: 19995115 BACKGROUND

• Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.

  PMID: 20484066 BACKGROUND

• Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y, Huang CY, Huang WQ, Liu KX. Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology. 2013 Apr;118(4):842-52. doi: 10.1097/ALN.0b013e3182850da5.

  PMID: 23353795 BACKGROUND

• Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S, Boylan J, Conlon N. Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1285-92. doi: 10.1053/j.jvca.2014.04.018.

  PMID: 25281045 BACKGROUND

• Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J, Yagoub H, Bashar K, O'Donnell M, Newell J, Canning C, McMonagle M, Dowdall J, Cross S, O'Daly S, Manning B, Fulton G, Kavanagh EG, Burke P, Grace PA, Moloney MC, Walsh SR; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery. Vasc Endovascular Surg. 2015 Nov;49(8):220-7. doi: 10.1177/1538574415614404. Epub 2015 Nov 16.

  PMID: 26574485 BACKGROUND

• Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.

  PMID: 27688236 BACKGROUND

• Thomas KN, Cotter JD, Williams MJ, van Rij AM. Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016 Apr;50(3):140-6. doi: 10.1177/1538574416639150. Epub 2016 Apr 12.

  PMID: 27075990 BACKGROUND

• Mouton R, Pollock J, Soar J, Mitchell DC, Rogers CA. Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial. Trials. 2015 Aug 25;16:377. doi: 10.1186/s13063-015-0899-3.

  PMID: 26303818 BACKGROUND

• De Freitas S, Hicks CW, Mouton R, Garcia S, Healy D, Connolly C, Thomas KN, Walsh SR. Effects of Ischemic Preconditioning on Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-analysis. J Surg Res. 2019 Mar;235:340-349. doi: 10.1016/j.jss.2018.09.049. Epub 2018 Nov 13.

  PMID: 30691816 BACKGROUND

• Sanchez-de-la-Torre A, Soler X, Barbe F, Flores M, Maisel A, Malhotra A, Rue M, Bertran S, Aldoma A, Worner F, Valls J, Lee CH, Turino C, Galera E, de Batlle J, Sanchez-de-la-Torre M; Spanish Sleep Network( *). Cardiac Troponin Values in Patients With Acute Coronary Syndrome and Sleep Apnea: A Pilot Study. Chest. 2018 Feb;153(2):329-338. doi: 10.1016/j.chest.2017.06.046. Epub 2017 Jul 20.

  PMID: 28736306 BACKGROUND

• Shah N, Redline S, Yaggi HK, Wu R, Zhao CG, Ostfeld R, Menegus M, Tracy D, Brush E, Appel WD, Kaplan RC. Obstructive sleep apnea and acute myocardial infarction severity: ischemic preconditioning? Sleep Breath. 2013 May;17(2):819-26. doi: 10.1007/s11325-012-0770-7. Epub 2012 Oct 23.

  PMID: 23090861 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

frozen blood plasma

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Reperfusion Injury

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Cundrle, M.D., Ph.D.

  St. Anne's University Hospital in Brno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Cundrle, M.D., Ph.D.

CONTACT

00420543182553; ivan.cundrle@fnusa.cz

Marek Lukes, M.D.

CONTACT

00420543182553; marek.lukes@fnusa.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 16, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)