Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.

NCT ID: NCT05557929

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-07-28

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Chronic Kidney Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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)

No interventions assigned to this group

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...

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pantelis Sarafidis, Professor

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, Greece

Locations

Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki

Thessaloniki, Thessalonikis, Greece

Countries

Greece

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Other Identifiers

ΔΔ4878

Identifier Type: -

Identifier Source: org_study_id