CompletedNCT05557929Updated Aug 22, 2023

Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.

An observational study in Chronic Kidney Disease Requiring Chronic Dialysis and Chronic Kidney Diseases, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type: Observational
Model: Other
Time perspective: Other
Enrollment: 28
Ages: 18 Years and older
Sex: All

Study 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. 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.

Conditions studied

Chronic Kidney Disease Requiring Chronic Dialysis
Chronic Kidney Diseases

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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 28 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

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Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Hemodialysis patients evaluated during the long and the shord dialysis interval Controls without kidney failure

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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...

Study design

Observational model: Other
Time perspective: Other
Enrollment: 28 participants (actual)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

Difference in VO2peak (ml/min/kg)
Difference in VO2peak (ml/min/kg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in VO2peak (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)

Secondary outcomes

Difference in Maximum workload (Watt)
Difference in Maximum workload (Watt) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in VCO2 (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in Heart Rate (bpm) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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
Difference in O2 pulse assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in VE (L/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in Tidal Volume, VT (ml) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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
Difference in Respiratory Rate, RR assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in PETCO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)
Difference in PETO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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
Difference in VE/VCO2 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.
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)

Other outcomes

Difference in Forced expiratory volume in one second, FEV1
Difference in Forced expiratory volume in one second, FEV1 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.
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 Forced vital capacity, FVC
Difference in Forced vital capacity, FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.
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 FEV1/FVC
Difference in FEV1/FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.
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 Total lung capacity, TLC
Difference in Total lung capacity, TLC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.
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 Residual volume, RV
Difference in Residual volume, RV assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.
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 Left ventricular mass index, LVMI
Difference in Left ventricular mass index, LVMI assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Left ventricular end-systolic volume, LVESV
Difference in Left ventricular end-systolic volume, LVESV assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Left ventricular end-diastolic volume, LVEDV
Difference in Left ventricular end-diastolic volume, LVEDV assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Global longitudinal strain, GLS
Difference in Global longitudinal strain, GLS assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Right ventricular free wall - RVFW GLS
Difference in Right ventricular free wall - RVFW GLS assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Tricuspid annular plane systolic excursion - TAPSE
Difference in Tricuspid annular plane systolic excursion - TAPSE assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Tissue Doppler imaging - TDI S
Difference in Tissue Doppler imaging - TDI S assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Pulmonary artery systolic pressure - PASP
Difference in Pulmonary artery systolic pressure - PASP assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 E/e
Difference in E/e assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 E/A
Difference in E/A assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Left atrial volume index - LAVi
Difference in Left atrial volume index - LAVi assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Left ventricular ejection fraction, LVEF
Difference in Left ventricular ejection fraction, LVEF assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Diameter of the inferior vena cava, IVC
Difference in Diameter of the inferior vena cava, IVC assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 B- lines' number
Difference in B- lines' number assessed with Lung Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.
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 Total body water, TBW
Difference in Total body water, TBW assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.
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 Fat-free mass, FFM
Difference in Fat-free mass, FFM assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.
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)

Study locations

1 site

Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki
Thessaloníki, Thessalonikis 54642, Greece

References and documents

Publications

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05557929
Lead sponsor: Aristotle University Of Thessaloniki
Responsible party: Sponsor
First posted: Sep 28, 2022
Start date: Dec 1, 2021
Primary completion: Jul 28, 2023
Completion: Jul 28, 2023
Last update: Aug 22, 2023

Study contacts

Pantelis Sarafidis, Professor

principal investigator · Aristotle University of Thessaloniki, Greece

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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