- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07746102
Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease
August 3, 2026 updated by: Katarzyna Peczek-Bartyzel, Medical University of Lodz
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michał Nowicki, Professor
- Phone Number: +48 42 201 44 00
- Email: nefro@wp.pl
Study Contact Backup
- Name: Katarzyna Pęczek-Bartyzel, MD PhD
- Phone Number: +48 42 201 44 00
- Email: katarzyna.peczek90@gmail.com
Study Locations
-
-
-
Lodz, Poland, 90-213
- Recruiting
- Medical University of Lodzi
-
Contact:
- Katarzyna Pęczek-Bartyzel, MD PhD
- Phone Number: 48422014400
- Email: katarzyna.peczek90@gmail.com
-
Contact:
- Email: katarzyna.peczek90@gmail.com
-
Sub-Investigator:
- Katarzyna Pęczek-Bartyzel, MD Phd
-
Principal Investigator:
- Michał Nowicki, Professor
-
Lodz, Poland, 92-219
- Recruiting
- Medical University of Lodzi
-
Contact:
- Katarzyna Pęczek-Bartyzel, MD PhD
- Phone Number: +48 42 201 44 00
- Email: katarzyna.peczek90@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Chronic hemodialyzed patients
Patients with chronic kidney disease (CKD) G5 during chronic hemodialysis
|
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
|
|
Other: Patient with CKD G1-G5
Patient with CKD G1-G5 without patients during chronic hemodialysis
|
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
|
|
Other: Control group
Patients without CKD
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of changes of parameter: Measurement of SIRT-1 [ng/]
Time Frame: 7 days
|
Measurement of SIRT-1 [ng/] at the beginning and 7 days
|
7 days
|
|
Assessment of changes of parameter blood saturation [%].
Time Frame: 7 days
|
at the beginning and 7 days
|
7 days
|
|
Assessment of IL-6
Time Frame: 7 days
|
Measurement of IL-6 [ng/ml] at the beginning and 7 days.
|
7 days
|
|
Assessment of Blood pressure
Time Frame: 7 days
|
Blood pressure [mmHg] will be checked at the beginning and 7 days
|
7 days
|
|
Assessment of heart beat/min
Time Frame: 7 days
|
will be checked at the beginning and 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 23, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
May 8, 2026
First Submitted That Met QC Criteria
August 3, 2026
First Posted (Actual)
August 4, 2026
Study Record Updates
Last Update Posted (Actual)
August 4, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Inflammation
- Renal Insufficiency, Chronic
Other Study ID Numbers
- ISP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.