HemodialysisNCT07746102
Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease
A study of Hemodialysis and Ischemia Preconditioning, run by Medical University of Lodz at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Ischemia Preconditioning, Chronic Kidney Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 23 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
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- severe anemia (Hb concentration<8g/dL),
- features of muscle cell damage (e.g. rhabdomyolysis),
- peripheral circulation disorders, peripheral vascular diseases.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Lodzi
Lodz, 90-213
Katarzyna Pęczek-Bartyzel, MD PhD, 48422014400, katarzyna.peczek90@gmail.com
katarzyna.peczek90@gmail.com
- Recruiting
Medical University of Lodzi
Lodz, 92-219
Katarzyna Pęczek-Bartyzel, MD PhD, +48 42 201 44 00, katarzyna.peczek90@gmail.com
About this study
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, Ischemia Preconditioning, Chronic Kidney Disease, Blood Pressure Disorders, Inflammation
- Being tested
- Preconditioning with control ischemic episodes
- Keywords
- Hemodialysis, ischemia preconditioning
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preconditioning with control ischemic episodesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Chronic hemodialyzed patients | Other | Patients with chronic kidney disease (CKD) G5 during chronic hemodialysis Receives: Other: Preconditioning with control ischemic episodes |
| Patient with CKD G1-G5 | Other | Patient with CKD G1-G5 without patients during chronic hemodialysis Receives: Other: Preconditioning with control ischemic episodes |
| Control group | Other | Patients without CKD Receives: Other: Preconditioning with control ischemic episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes of parameter: Measurement of SIRT-1 [ng/]
Measurement of SIRT-1 [ng/] at the beginning and 7 days
Measured: 7 days
Assessment of changes of parameter blood saturation [%].
at the beginning and 7 days
Measured: 7 days
Assessment of IL-6
Measurement of IL-6 [ng/ml] at the beginning and 7 days.
Measured: 7 days
Assessment of Blood pressure
Blood pressure [mmHg] will be checked at the beginning and 7 days
Measured: 7 days
Assessment of heart beat/min
will be checked at the beginning and 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start23 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Peczek-Bartyzel, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746102
- Sponsor's protocol ID
- ISP1
- Status last verified
- Jun 2026
- First submitted
- 8 May 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39319450Lang 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.
PubMed 35596644Przyklenk 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.
PubMed 21821525
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07746102
- Acronym / sponsor ID
- ISP1
- Conditions
- Hemodialysis, Ischemia Preconditioning, Chronic Kidney Disease, Blood Pressure Disorders, Inflammation
- Keywords
- Hemodialysis, ischemia preconditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 23 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic hemodialyzed patients | Other | Other: Preconditioning with control ischemic episodesPatients with chronic kidney disease (CKD) G5 during chronic hemodialysis |
| Patient with CKD G1-G5 | Other | Other: Preconditioning with control ischemic episodesPatient with CKD G1-G5 without patients during chronic hemodialysis |
| Control group | Other | Other: Preconditioning with control ischemic episodesPatients without CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preconditioning with control ischemic episodes4 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 | Chronic hemodialyzed patients, Control group, Patient with CKD G1-G5 |
Primary outcome
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
Assessment of changes of parameter blood saturation [%].
Time frame: 7 days
at the beginning and 7 days
Assessment of IL-6
Time frame: 7 days
Measurement of IL-6 [ng/ml] at the beginning and 7 days.
Assessment of Blood pressure
Time frame: 7 days
Blood pressure [mmHg] will be checked at the beginning and 7 days
Assessment of heart beat/min
Time frame: 7 days
will be checked at the beginning and 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 39319450Jia 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.
- Background: PubMed 35596644Lang 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.
- Background: PubMed 21821525Przyklenk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hemodialysis and Ischemia Preconditioning, run by Medical University of Lodz at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michał Nowicki, Professor (+48 42 201 44 00, nefro@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes of parameter: Measurement of SIRT-1 [ng/] (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07746102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.