Abdominal Aortic Aneurysm, Carotid Artery Stenosis, Peripheral Artery Disease
Conditions
Keywords
Atherosclerosis
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.
Interventions
PROCEDURERemote 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.
PROCEDUREControl 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.
Sponsors
Tartu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patient, patient's physician, surgeon, anaesthesiologist and everyone else in the surgical team were blinded to study intervention. Blinding was attained with manometer's scale covered. Second arterial stiffness measurement was carried out by a study member who did not know the patient's group affiliation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 1- year mortality | 1 year | — |
| Complications of remote ishcaemic preconditioning | 10 days | Upper-extremity deep vein thrombosis, Acute upper limb ischaemia. |
| 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. |
| Cardiac event | 10 days | Myocardial infarction or cardiac arrest |
| Duration of intesive care unit stay | 30 days | — |
| 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 |
| Duration of hospital stay | 30 days | — |
| Postoperative complications | 10 days | Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection. |
Countries
Estonia
Outcome results
None listed