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

Tartu University Hospital98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Abdominal Aortic Aneurysm Peripheral Artery Disease Carotid Artery Stenosis

Interventions

Remote ischaemic preconditioningPROCEDURE

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.

Control to RIPCPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tartu University Hospital

Tartu, Tartu County, Estonia

Outcomes

Primary Outcomes

Carotide-femoral pulse velocity

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Time frame: 24 h

Augmentation index

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Time frame: 24 h

Secondary Outcomes

Cardiac markers

Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).

Time frame: 24 h

Traditional biomarkers of renal function

Creatinine, Urea

Time frame: 24 h

Markers of inflammation and oxidative stress

Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.

Time frame: 24 h

Duration of hospital stay

Time frame: 30 days

Duration of intesive care unit stay

Time frame: 30 days

Cardiac event

Myocardial infarction or cardiac arrest

Time frame: 10 days

Postoperative complications

Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.