Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.

Chronic Kidney Diseases Clinical Trial

Official title:

Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05557929
• Other study ID #: ??4878
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: July 28, 2023

Study information

• Verified date: August 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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...

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Greece	Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki	Thessaloníki	Thessalonikis

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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	Difference in Forced vital capacity, FVC	Difference in Forced vital capacity, FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in FEV1/FVC	Difference in FEV1/FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Total lung capacity, TLC	Difference in Total lung capacity, TLC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Residual volume, RV	Difference in Residual volume, RV assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	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.	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	Difference in E/e	Difference in E/e assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in E/A	Difference in E/A assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.	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	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.	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	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.	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	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.	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	Difference in B- lines' number	Difference in B- lines' number assessed with Lung Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.	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	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.	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	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.	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)
Primary	Difference in VO2peak (ml/min/kg)	Difference in VO2peak (ml/min/kg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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)
Primary	Difference in VO2peak ((ml/min)	Difference in VO2peak (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Maximum workload (Watt)	Difference in Maximum workload (Watt) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in VCO2 (ml/min)	Difference in VCO2 (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Heart Rate (bpm)	Difference in Heart Rate (bpm) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in O2 pulse	Difference in O2 pulse assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in VE (L/min)	Difference in VE (L/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Tidal Volume, VT (ml)	Difference in Tidal Volume, VT (ml) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in Respiratory Rate, RR	Difference in Respiratory Rate, RR assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in PETCO2 (mmHg)	Difference in PETCO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in PETO2 (mmHg)	Difference in PETO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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	Difference in VE/VCO2	Difference in VE/VCO2 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.	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)