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

NCT07746102 | Recruiting

• 1 other identifier: ISP1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemodialysis; Blood Pressure Disorders; Inflammation; Ischemia Preconditioning; Chronic Kidney Disease

Keywords

Hemodialysis; ischemia preconditioning

Outcome Measures

Primary Outcomes (5)

• Assessment of changes of parameter: Measurement of SIRT-1 [ng/]

  Measurement of SIRT-1 \[ng/\] at the beginning and 7 days

  7 days

• Assessment of changes of parameter blood saturation [%].

  at the beginning and 7 days

  7 days

• Assessment of IL-6

  Measurement of IL-6 \[ng/ml\] at the beginning and 7 days.

  7 days

• Assessment of Blood pressure

  Blood pressure \[mmHg\] will be checked at the beginning and 7 days

  7 days

• Assessment of heart beat/min

  will be checked at the beginning and 7 days

  7 days

Study Arms (3)

Chronic hemodialyzed patients

OTHER

Patients with chronic kidney disease (CKD) G5 during chronic hemodialysis

Other: Preconditioning with control ischemic episodes

Patient with CKD G1-G5

OTHER

Patient with CKD G1-G5 without patients during chronic hemodialysis

Other: Preconditioning with control ischemic episodes

Control group

OTHER

Patients without CKD

Other: Preconditioning with control ischemic episodes

Interventions

Preconditioning with control ischemic episodes OTHER

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

Chronic hemodialyzed patients; Control group; Patient with CKD G1-G5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (2)

Medical University of Lodzi

Lodz, 90-213, Poland

RECRUITING

Medical University of Lodzi

Lodz, 92-219, Poland

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michał Nowicki, Professor

CONTACT

+48 42 201 44 00; nefro@wp.pl

Katarzyna Pęczek-Bartyzel, MD PhD

CONTACT

+48 42 201 44 00; katarzyna.peczek90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: August 4, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-06

Locations

PL (2)