Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05557929
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Chronic Dialysis; Chronic Kidney Diseases

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

• Study Type: Observational
• Anticipated Enrollment: 28 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Difference in VO2peak (ml/min/kg) [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.

2. Difference in VO2peak ((ml/min) [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.

Secondary Outcome Measures

1. Difference in Maximum workload (Watt) [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 Maximum workload (Watt) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

2. Difference in VCO2 (ml/min) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

3. Difference in Heart Rate (bpm) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

4. Difference in O2 pulse [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 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

5. Difference in VE (L/min) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

6. Difference in Tidal Volume, VT (ml) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

7. Difference in Respiratory Rate, RR [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 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

8. Difference in PETCO2 (mmHg) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

9. Difference in PETO2 (mmHg) [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) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

10. Difference in VE/VCO2 [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 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

Other Outcome Measures

1. Difference in Forced expiratory volume in one second, FEV1 [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 expiratory volume in one second, FEV1 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

2. Difference in Forced vital capacity, FVC [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 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

3. Difference in FEV1/FVC [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 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

4. Difference in Total lung capacity, TLC [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 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

5. Difference in Residual volume, RV [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 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

6. Difference in Left ventricular mass index, LVMI [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

7. Difference in Left ventricular end-systolic volume, LVESV [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

8. Difference in Left ventricular end-diastolic volume, LVEDV [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

9. Difference in Global longitudinal strain, GLS [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

10. Difference in Right ventricular free wall - RVFW GLS [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

11. Difference in Tricuspid annular plane systolic excursion - TAPSE [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

12. Difference in Tissue Doppler imaging - TDI S [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

13. Difference in Pulmonary artery systolic pressure - PASP [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

14. Difference in E/e [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

15. Difference in E/A [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

16. Difference in Left atrial volume index - LAVi [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

17. Difference in Left ventricular ejection fraction, LVEF [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

18. Difference in Diameter of the inferior vena cava, IVC [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 assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

19. Difference in B- lines' number [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 assessed with Lung Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

20. Difference in Total body water, TBW [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 assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.

21. Difference in Fat-free mass, FFM [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 assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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...

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki	Thessaloníki	Thessalonikis	Greece	54642

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Principal Investigator: Pantelis Sarafidis, Professor, Aristotle University of Thessaloniki, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05557929
• Other Study ID Numbers: ΔΔ4878
• First Posted: Sep 28, 2022
• Last Update Posted: Sep 28, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 28, 2022