A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.

Conditions
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Abdominal Aortic Aneurysm, Peripheral Artery Disease, Carotid Artery Stenosis

Intervention / Treatment
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* Procedure: Remote ischaemic preconditioning
* Procedure: Control to RIPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are willing to give full informed consent for participation and who are undergoing open abdominal aortic aneurysm repair or who are undergoing endovascular aortic aneurysm repair or who are undergoing lower limb revascularization surgery or who are undergoing carotid endarterectomy Exclusion Criteria: patients under age of 18 patients who are pregnant patients with known malignancy during last 5 years patients with permanent atrial fibrillation or flutter patients with symptomatic upper limb atherosclerosis patients who require home oxygen therapy patients with eGFR < 30 ml/min/1.73 m2, measured preoperatively patients who have had myocardial infarction during last month patients who have had upper limb vein thrombosis patients who have undergone vascular surgery in the axillary region patients who are not able to follow the study regimen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischaemic preconditioning<br>Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion. | Procedure: Remote ischaemic preconditioning<br>* Ischaemia is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 200 mm Hg or to a value that is 20 mm Hg greater than the patient's systolic blood pressure - if the patient's systolic blood pressure is more than 180 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.<br>* Other names: RIPC;|
| Sham Comparator: Control to RIPC<br>Four episodes of 5 minutes during which the pressure in the cuff is equal to venous pressure are performed. Between all the episodes there is a 5-minute pause. | Procedure: Control to RIPC<br>* Venous pressure is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 10-20 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotide-femoral pulse velocity | Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery | 24 h | 
| Augmentation index | Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac markers | Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP). | 24 h | 
| Traditional biomarkers of renal function | Creatinine, Urea | 24 h | 
| Markers of inflammation and oxidative stress | Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane. | 24 h | 
| Duration of hospital stay |  | 30 days | 
| Duration of intesive care unit stay |  | 30 days | 
| Cardiac event | Myocardial infarction or cardiac arrest | 10 days | 
| Postoperative complications | Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection. | 10 days | 
| 1- year mortality |  | 1 year | 
| Complications of remote ishcaemic preconditioning | Upper-extremity deep vein thrombosis, Acute upper limb ischaemia. | 10 days | 
| Novel biomarkers of renal function | Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M), | 24 h | 
| Estimated glomerular filtration rate | eGFR | 24 h | 
| Low molecular-weight metabolites | Acylcarnitines Amino acids: leucine, ornithine, methionine, alanine, phenylalanine, valine, glutamate, tyrosine, glycine, arginine, citrulline, asparagine, aspartate, glutamine, histidine, lysine, proline, tryptophan, serine, threonine, cysteine and hydroxyproline. Hydroxy acids: citrate, α-oxoglutarate, pyruvate, succinate, mallonic acid, β-hydroxybutyrate, cis-aconitic acid and oxaloacetate. | 24 h | 
| Arterial elasticity indices | Measured with HDI pulsewave CR-200 baseline characteristics are measured before surgery measuring is repeated 24 h after surgery | 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis