Chronic Kidney Disease Requiring Chronic DialysisNCT05557929
Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Chronic Kidney Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Chronic kidney disease (CKD), especially end-stage kidney disease (ESKD), is associated with increased risk for cardiovascular events and all-cause mortality. Exercise intolerance as well as reduced cardiovascular reserve are extremely common in patients with CKD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Chronic Kidney Diseases
- How many people
- 28 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 28 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Hemodialysis patients evaluated during the long and the shord dialysis interval Controls without kidney failure
Who may be able to join
- Hemodialysis patients aged >18 years.
- Patients with a total duration of hemodialysis >3 months.
- Patients enrolled in a dialysis program that includes three sessions per week.
- Hemodialysis patients who are capable of exercising on a cycle ergometer.
- Hemodialysis patients who are capable of understanding and providing written, signed consent to participate in the study
Who cannot join
- Absolute and relative contraindications for performing CPET according to the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP), such as
- Acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
- Syncope
- Active endocarditis
Show all 19Show fewer
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary oedema
- Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (ie, infection, renal failure, thyrotoxicosis)
- Mental impairment leading to inability to cooperate
- Orthopaedic impairment that compromises exercise performance
- Electrolyte abnormalities
- Advanced or complicated pregnancy...
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki
Thessaloniki, Thessalonikis, 54642
About this study
Official title: Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.
Chronic kidney disease (CKD), especially end-stage kidney disease (ESKD), is associated with increased risk for cardiovascular events and all-cause mortality. Exercise intolerance as well as reduced cardiovascular reserve are extremely common in patients with CKD. Cardiopulmonary exercise testing (CPET) is a non-invasive, dynamic technique that provides an integrative evaluation of cardiovascular, pulmonary, neuropsychological and metabolic function during maximal or submaximal exercise, allowing the evaluation of functional reserves of these systems. CPET is currently considered to be the gold-standard for identifying exercise limitation and differentiating its causes. It has been widely used in several medical fields for risk stratification, clinical evaluation and other applications. However, the use of CPET in assessment of exercise intolerance in everyday nephrology practice is limited. Hence, this is the first study possible differences in CPET's parameters during long and short interdialytic intervals in hemodialysis patients.
Read the detailed description
This is an observational study with a cross-over design performed in the Department of Nephrology and the Third Department of Cardiology in Hippokration Hospital of Thessaloniki in Greece. For the purposes of this study, hemodialysis patients fulfilling the inclusion/exclusion criteria, as well as controls without CKD, were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.
Baseline evaluation includes the recording of demographics and anthropometric characteristics, medical history, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. Hemodialysis patients will be evaluated at two time points (at the end of the long and at the end of the short interdialytic interval), while controls at one time point. All the participants will undergo spirometry, CPET, cardiac ultrasound, lung ultrasound and bioelectrical impedance analysis.
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | The present study will comparatively evaluate a series of parameters (measured with cardiopulmonary exercise testing, spirometry, heart ultrasound, lung ultrasound and bioelectrical impedance analysis) in end-stage kidney disease patients undergoing hemodialysis between the end of the long and the end of the short interdialytic interval. The primary aim of the study is the evaluation of cardiorespiratory fitness - cardiovascular reserve assessed with cardiopulmonary exercise testing at these time points. | |
| Controls without CKD | Controls without CKD will be evaluated with cardiopulmonary exercise testing, spirometry, heart ultrasound, lung ultrasound and bioelectrical impedance analysis at one time point (baseline visit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VO2peak (ml/min/kg)
Difference in VO2peak (ml/min/kg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VO2peak ((ml/min)
Difference in VO2peak (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Secondary outcomes (10)
Difference in Maximum workload (Watt)
Difference in Maximum workload (Watt) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VCO2 (ml/min)
Difference in VCO2 (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Heart Rate (bpm)
Difference in Heart Rate (bpm) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in O2 pulse
Difference in O2 pulse assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VE (L/min)
Difference in VE (L/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Tidal Volume, VT (ml)
Difference in Tidal Volume, VT (ml) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Respiratory Rate, RR
Difference in Respiratory Rate, RR assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in PETCO2 (mmHg)
Difference in PETCO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in PETO2 (mmHg)
Difference in PETO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VE/VCO2
Difference in VE/VCO2 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Measured: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Dec 2021
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pantelis Sarafidis, Professor, Principal investigator, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557929
- Sponsor's protocol ID
- ΔΔ4878
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.
PubMed 23989362Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32(5 Suppl 3):S112-9. doi: 10.1053/ajkd.1998.v32.pm9820470. No abstract available.
PubMed 9820470London GM, Drueke TB. Atherosclerosis and arteriosclerosis in chronic renal failure. Kidney Int. 1997 Jun;51(6):1678-95. doi: 10.1038/ki.1997.233. No abstract available.
PubMed 9186855Wolf M. Forging forward with 10 burning questions on FGF23 in kidney disease. J Am Soc Nephrol. 2010 Sep;21(9):1427-35. doi: 10.1681/ASN.2009121293. Epub 2010 May 27.
PubMed 20507943Bernheim J, Benchetrit S. The potential roles of FGF23 and Klotho in the prognosis of renal and cardiovascular diseases. Nephrol Dial Transplant. 2011 Aug;26(8):2433-8. doi: 10.1093/ndt/gfr208. Epub 2011 May 4.
PubMed 21543658Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
PubMed 19861670Georgianos PI, Sarafidis PA. Pro: Should we move to more frequent haemodialysis schedules? Nephrol Dial Transplant. 2015 Jan;30(1):18-22. doi: 10.1093/ndt/gfu381. Epub 2014 Dec 23.
PubMed 25538158Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
PubMed 26925525Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9. doi: 10.1046/j.1523-1755.1999.00391.x.
PubMed 10201022Foley RN, Gilbertson DT, Murray T, Collins AJ. Long interdialytic interval and mortality among patients receiving hemodialysis. N Engl J Med. 2011 Sep 22;365(12):1099-107. doi: 10.1056/NEJMoa1103313.
PubMed 21992122Zhang H, Schaubel DE, Kalbfleisch JD, Bragg-Gresham JL, Robinson BM, Pisoni RL, Canaud B, Jadoul M, Akiba T, Saito A, Port FK, Saran R. Dialysis outcomes and analysis of practice patterns suggests the dialysis schedule affects day-of-week mortality. Kidney Int. 2012 Jun;81(11):1108-15. doi: 10.1038/ki.2011.481. Epub 2012 Feb 1.
PubMed 22297673Tsilonis K, Sarafidis PA, Kamperidis V, Loutradis C, Georgianos PI, Imprialos K, Ziakas A, Sianos G, Nikolaidis P, Lasaridis AN, Karvounis H. Echocardiographic Parameters During Long and Short Interdialytic Intervals in Hemodialysis Patients. Am J Kidney Dis. 2016 Nov;68(5):772-781. doi: 10.1053/j.ajkd.2016.06.017. Epub 2016 Aug 18.
PubMed 27545351Koutroumbas G, Georgianos PI, Sarafidis PA, Protogerou A, Karpetas A, Vakianis P, Raptis V, Liakopoulos V, Panagoutsos S, Syrganis C, Passadakis P. Ambulatory aortic blood pressure, wave reflections and pulse wave velocity are elevated during the third in comparison to the second interdialytic day of the long interval in chronic haemodialysis patients. Nephrol Dial Transplant. 2015 Dec;30(12):2046-53. doi: 10.1093/ndt/gfv090. Epub 2015 Apr 28.
PubMed 25920919
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT05557929
- Acronym / sponsor ID
- ΔΔ4878
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 28 Sep 2022 (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.
Chronic kidney disease (CKD), especially end-stage kidney disease (ESKD), is associated with increased risk for cardiovascular events and all-cause mortality. Exercise intolerance as well as reduced cardiovascular reserve are extremely common in patients with CKD. Cardiopulmonary exercise testing (CPET) is a non-invasive, dynamic technique that provides an integrative evaluation of cardiovascular, pulmonary, neuropsychological and metabolic function during maximal or submaximal exercise, allowing the evaluation of functional reserves of these systems. CPET is currently considered to be the gold-standard for identifying exercise limitation and differentiating its causes. It has been widely used in several medical fields for risk stratification, clinical evaluation and other applications. However, the use of CPET in assessment of exercise intolerance in everyday nephrology practice is limited. Hence, this is the first study possible differences in CPET's parameters during long and short interdialytic intervals in hemodialysis patients.
Detailed description
This is an observational study with a cross-over design performed in the Department of Nephrology and the Third Department of Cardiology in Hippokration Hospital of Thessaloniki in Greece. For the purposes of this study, hemodialysis patients fulfilling the inclusion/exclusion criteria, as well as controls without CKD, were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.
Baseline evaluation includes the recording of demographics and anthropometric characteristics, medical history, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. Hemodialysis patients will be evaluated at two time points (at the end of the long and at the end of the short interdialytic interval), while controls at one time point. All the participants will undergo spirometry, CPET, cardiac ultrasound, lung ultrasound and bioelectrical impedance analysis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | –The present study will comparatively evaluate a series of parameters (measured with cardiopulmonary exercise testing, spirometry, heart ultrasound, lung ultrasound and bioelectrical impedance analysis) in end-stage kidney disease patients undergoing hemodialysis between the end of the long and the end of the short interdialytic interval. The primary aim of the study is the evaluation of cardiorespiratory fitness - cardiovascular reserve assessed with cardiopulmonary exercise testing at these time points. |
| Controls without CKD | – | –Controls without CKD will be evaluated with cardiopulmonary exercise testing, spirometry, heart ultrasound, lung ultrasound and bioelectrical impedance analysis at one time point (baseline visit) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients evaluated during the long and the shord dialysis interval Controls without kidney failure
Key inclusion criteria (5 listed)
- Hemodialysis patients aged >18 years.
- Patients with a total duration of hemodialysis >3 months.
- Patients enrolled in a dialysis program that includes three sessions per week.
- Hemodialysis patients who are capable of exercising on a cycle ergometer.
- Hemodialysis patients who are capable of understanding and providing written, signed consent to participate in the study
Key exclusion criteria (19 listed)
- Absolute and relative contraindications for performing CPET according to the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP), such as
- Acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
- Syncope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in VO2peak (ml/min/kg)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VO2peak (ml/min/kg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
Difference in VO2peak ((ml/min)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VO2peak (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
10 secondary outcomes
Difference in Maximum workload (Watt)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VCO2 (ml/min)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Heart Rate (bpm)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in O2 pulse
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VE (L/min)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Tidal Volume, VT (ml)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in Respiratory Rate, RR
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in PETCO2 (mmHg)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in PETO2 (mmHg)
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Difference in VE/VCO2
Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 23989362Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.
- Background: PubMed 9820470Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32(5 Suppl 3):S112-9. doi: 10.1053/ajkd.1998.v32.pm9820470. No abstract available.
- Background: PubMed 9186855London GM, Drueke TB. Atherosclerosis and arteriosclerosis in chronic renal failure. Kidney Int. 1997 Jun;51(6):1678-95. doi: 10.1038/ki.1997.233. No abstract available.
- Background: PubMed 20507943Wolf M. Forging forward with 10 burning questions on FGF23 in kidney disease. J Am Soc Nephrol. 2010 Sep;21(9):1427-35. doi: 10.1681/ASN.2009121293. Epub 2010 May 27.
- Background: PubMed 21543658Bernheim J, Benchetrit S. The potential roles of FGF23 and Klotho in the prognosis of renal and cardiovascular diseases. Nephrol Dial Transplant. 2011 Aug;26(8):2433-8. doi: 10.1093/ndt/gfr208. Epub 2011 May 4.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 19861670de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
- Background: PubMed 25538158Georgianos PI, Sarafidis PA. Pro: Should we move to more frequent haemodialysis schedules? Nephrol Dial Transplant. 2015 Jan;30(1):18-22. doi: 10.1093/ndt/gfu381. Epub 2014 Dec 23.
- Background: PubMed 26925525Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
- Background: PubMed 10201022Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9. doi: 10.1046/j.1523-1755.1999.00391.x.
- Background: PubMed 21992122Foley RN, Gilbertson DT, Murray T, Collins AJ. Long interdialytic interval and mortality among patients receiving hemodialysis. N Engl J Med. 2011 Sep 22;365(12):1099-107. doi: 10.1056/NEJMoa1103313.
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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. This study is not recruiting at the moment.
Pantelis Sarafidis, Professor principal investigator
Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Chronic Kidney Diseases, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 19 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in VO2peak (ml/min/kg) (time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)). The study lists 2 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 NCT05557929, which also lists 43 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 22 Aug 2023.