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

Peripheral Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689414
• Other study ID #: 16004
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: February 26, 2018
• Start date: January 2016
• Est. completion date: February 2019

Study information

• Verified date: February 2018
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2019
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Atherosclerosis
• Carotid Artery Stenosis
• Carotid Stenosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Procedure:
• Remote ischaemic preconditioning
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 RIPC
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.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartu County

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotide-femoral pulse velocity	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	24 h
Primary	Augmentation index	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	24 h
Secondary	Cardiac markers	Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).	24 h
Secondary	Traditional biomarkers of renal function	Creatinine, Urea	24 h
Secondary	Markers of inflammation and oxidative stress	Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.	24 h
Secondary	Duration of hospital stay		30 days
Secondary	Duration of intesive care unit stay		30 days
Secondary	Cardiac event	Myocardial infarction or cardiac arrest	10 days
Secondary	Postoperative complications	Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.	10 days
Secondary	1- year mortality		1 year
Secondary	Complications of remote ishcaemic preconditioning	Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.	10 days
Secondary	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, ß2 microglobulin (B2M),	24 h
Secondary	Estimated glomerular filtration rate	eGFR	24 h
Secondary	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, a-oxoglutarate, pyruvate, succinate, mallonic acid, ß-hydroxybutyrate, cis-aconitic acid and oxaloacetate.	24 h
Secondary	Arterial elasticity indices	Measured with HDI pulsewave CR-200; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	24 h