Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease

Обзор

The aim of our study is to evaluate the impact of repeated episodes of ischemic quenching on changes in blood pressure, heart rate and laboratory parameters of inflammation in patients with kidney diseases. There is credible evidence that intentionally producing periods of ischemia provides protection of the myocardium and blood vessels against subsequent ischemic injury. The examination will be performed during hospitalization in the Department of Nephrology, Hypertension, Transplantology and Internal Diseases and will last 4 days. On the first day, blood pressure will be measured using an automatic blood pressure monitor, radial artery pulse, blood saturation will be measured using a pulse oximeter, and approximately 6 ml of venous blood will be collected from the elbow bend area for laboratory tests. Then, compression of the lower limb below the knee will be performed using a blood pressure cuff. Four 5-minute cycles of inflation and deflation of the cuff will be performed. The pressure on the lower limb will be repeated on the next two days. On the last day of the examination, blood pressure, heart rate and blood saturation will be measured again, and approximately 6 ml of venous blood will be collected again for laboratory tests.

Вмешательства

• Другое Preconditioning with control ischemic episodes
  4 cycles of 5-minute inflation and deflation using a sphygmomanometer cuff at a pressure of 30 mmHg above the systolic value through three consecutive days

Первичные конечные точки

• Assessment of changes of parameter: Measurement of SIRT-1 [ng/] [Срок оценки: 7 days]
• Assessment of changes of parameter blood saturation [%]. [Срок оценки: 7 days]
• Assessment of IL-6 [Срок оценки: 7 days]
• Assessment of Blood pressure [Срок оценки: 7 days]
• Assessment of heart beat/min [Срок оценки: 7 days]

Критерии участия

Критерии включения

• obtaining the patient's voluntary, informed consent to participate in the experiment,
• chronic kidney disease in stages G1-G5,
• women and men over 18 years of age.
• failure to meet the qualification criteria for participation in the study,
• consciousness disorders,
• heart failure (NYHA IV),
• severe anemia (Hb concentration<8g/dL),
• features of muscle cell damage (e.g. rhabdomyolysis),
• peripheral circulation disorders, peripheral vascular diseases.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Польша · 2 центра

• Medical University of Lodzi — Lodz
• Medical University of Lodzi — Lodz

Публикации

• Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25. PMID 39319450
• Lang JA, Kim J. Remote ischaemic preconditioning - translating cardiovascular benefits to humans. J Physiol. 2022 Jul;600(13):3053-3067. doi: 10.1113/JP282568. Epub 2022 May 31. PMID 35596644
• Przyklenk K, Whittaker P. Remote ischemic preconditioning: current knowledge, unresolved questions, and future priorities. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):255-9. doi: 10.1177/1074248411409040. PMID 21821525

Идентификаторы

NCT: NCT07746102 · ISP1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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