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

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm; Peripheral Artery Disease; Carotid Artery Stenosis
• Interventions: Procedure: Control to RIPC; Procedure: Remote ischaemic preconditioning

• Registration Number: NCT02689414
• Lead Sponsor: Tartu University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Status Verified: 2018-02
• Primary Completion: 2018-02-08
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control to RIPC	Control to RIPC	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.
Remote ischaemic preconditioning	Remote ischaemic preconditioning	Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.

Primary Outcome Measures

Name	Time	Method
Carotide-femoral pulse velocity	24 h	Measured with Sphygmocor XCEL; * baseline characteristics are measured before surgery; * measuring is repeated 24 h after surgery
Augmentation index	24 h	Measured with Sphygmocor XCEL; * baseline characteristics are measured before surgery; * measuring is repeated 24 h after surgery

Secondary Outcome Measures

Name	Time	Method
Cardiac markers	24 h	Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).
Traditional biomarkers of renal function	24 h	Creatinine, Urea
Markers of inflammation and oxidative stress	24 h	Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.
Duration of hospital stay	30 days
Duration of intesive care unit stay	30 days
Cardiac event	10 days	Myocardial infarction or cardiac arrest
Postoperative complications	10 days	Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.
1- year mortality	1 year
Complications of remote ishcaemic preconditioning	10 days	Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.
Novel biomarkers of renal function	24 h	Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M),
Estimated glomerular filtration rate	24 h	eGFR
Low molecular-weight metabolites	24 h	* 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.
Arterial elasticity indices	24 h	Measured with HDI pulsewave CR-200; * baseline characteristics are measured before surgery; * measuring is repeated 24 h after surgery

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartu County, Estonia