Clinical trial NCT05557929: Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.
Official title: Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Chronic Kidney Diseases
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients evaluated during the long and the shord dialysis interval Controls without kidney failure

Brief 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.

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.

Eligibility criteria: 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:

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...

Primary outcomes:
measure: Difference in VO2peak (ml/min/kg)
timeFrame: 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)
measure: Difference in VO2peak ((ml/min)
timeFrame: 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:
measure: Difference in Maximum workload (Watt)
timeFrame: 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)
measure: Difference in VCO2 (ml/min)
timeFrame: 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)
measure: Difference in Heart Rate (bpm)
timeFrame: 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)
measure: Difference in O2 pulse
timeFrame: 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)
measure: Difference in VE (L/min)
timeFrame: 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)
measure: Difference in Tidal Volume, VT (ml)
timeFrame: 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)
measure: Difference in Respiratory Rate, RR
timeFrame: 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)
measure: Difference in PETCO2 (mmHg)
timeFrame: 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)
measure: Difference in PETO2 (mmHg)
timeFrame: 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)
measure: Difference in VE/VCO2
timeFrame: 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:
measure: Difference in Forced expiratory volume in one second, FEV1
timeFrame: 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)
measure: Difference in Forced vital capacity, FVC
timeFrame: 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)
measure: Difference in FEV1/FVC
timeFrame: 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)
measure: Difference in Total lung capacity, TLC
timeFrame: 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)
measure: Difference in Residual volume, RV
timeFrame: 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)
measure: Difference in Left ventricular mass index, LVMI
timeFrame: 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)
measure: Difference in Left ventricular end-systolic volume, LVESV
timeFrame: 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)
measure: Difference in Left ventricular end-diastolic volume, LVEDV
timeFrame: 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)
measure: Difference in Global longitudinal strain, GLS
timeFrame: 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)
measure: Difference in Right ventricular free wall - RVFW GLS
timeFrame: 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)
measure: Difference in Tricuspid annular plane systolic excursion - TAPSE
timeFrame: 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)
measure: Difference in Tissue Doppler imaging - TDI S
timeFrame: 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)
measure: Difference in Pulmonary artery systolic pressure - PASP
timeFrame: 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)
measure: Difference in E/e
timeFrame: 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)
measure: Difference in E/A
timeFrame: 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)
measure: Difference in Left atrial volume index - LAVi
timeFrame: 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)
measure: Difference in Left ventricular ejection fraction, LVEF
timeFrame: 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)
measure: Difference in Diameter of the inferior vena cava, IVC
timeFrame: 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)
measure: Difference in B- lines' number
timeFrame: 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)
measure: Difference in Total body water, TBW
timeFrame: 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)
measure: Difference in Fat-free mass, FFM
timeFrame: 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)
Locations:
city: Thessaloníki
country: Greece
facility: Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki
state: Thessalonikis
Study officials:
affiliation: Aristotle University of Thessaloniki, Greece
name: Pantelis Sarafidis, Professor
role: PRINCIPAL_INVESTIGATOR
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