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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischaemic preconditioning | Experimental | Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion. |
|
| Control to RIPC | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischaemic preconditioning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Carotide-femoral pulse velocity | Measured with Sphygmocor XCEL
| 24 h |
| Augmentation index | Measured with Sphygmocor XCEL
| 24 h |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urmas Lepner, MD-PhD | Tartu University Hospital | Study Chair |
| Joel Starkopf, MD-PhD | Tartu University Hospital | Study Chair |
| Mihkel Zilmer, MD-PhD | University of Tartu | Study Chair |
| Jaak Kals, MD-PhD | Tartu University Hospital | Principal Investigator |
| Karl Kuusik, MD | University of Tartu | Study Chair |
| Teele Kepler, MD | University of Tartu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | Tartu County | 50406 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645250 | Derived | Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. | |
| 32968425 | Derived | Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote ischaemic preconditioning influences the levels of acylcarnitines in vascular surgery: a randomised clinical trial. Nutr Metab (Lond). 2020 Sep 18;17:76. doi: 10.1186/s12986-020-00495-3. eCollection 2020. |
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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.
|
|
| Control to RIPC | Procedure | 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. |
|
| 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 |
| 24 h |
| Arterial elasticity indices | Measured with HDI pulsewave CR-200
| 24 h |
| 32047578 | Derived | Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote Ischaemic Preconditioning Reduces Kidney Injury Biomarkers in Patients Undergoing Open Surgical Lower Limb Revascularisation: A Randomised Trial. Oxid Med Cell Longev. 2020 Jan 23;2020:7098505. doi: 10.1155/2020/7098505. eCollection 2020. |
| 31126835 | Derived | Kepler T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Lieberg J, Vahi M, Kals J. The Effect of Remote Ischaemic Preconditioning on Arterial Stiffness in Patients Undergoing Vascular Surgery: A Randomised Clinical Trial. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):868-875. doi: 10.1016/j.ejvs.2018.12.002. Epub 2019 May 22. |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D058729 | Peripheral Arterial Disease |
| D016893 | Carotid Stenosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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