Rheological Functions of Erythrocyte in ESRD
ConditionEnd-stage Renal Disease (ESRD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorChang Gung Memorial Hospital
About this trial
End-stage renal disease (ESRD) disrupts erythrocyte deformability due to osmotic imbalances, oxidative stress, and uremic toxins, leading to impaired microcirculation and oxygen transport. Dysregulation of ion channels, particularly the Gardos channel, exacerbates dehydration and eryptosis, further compromising vascular integrity. Given the critical role of erythrocyte flexibility in oxygen delivery, this study investigates its relationship with aerobic capacity in ESRD patients, highlighting potential mechanisms of microvascular dysfunction
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Receiving hemodialysis and medication at least for 6 weeks
Kt/V score > 1.2
Disqualifiers
Under 20 years-old
Hyperkalemia occurs within 3 month
Having orthopedic or muscular diseases
Other concerned medical, psychological or physiological diseases
Trial population
This study included 18 patients with end-stage renal disease (ESRD) and 18 age-matched healthy controls. ESRD patients were recruited and with inclusion criteria requiring a confirmed diagnosis of ESRD and stable dialysis treatment for at least three months. Healthy controls were free of chronic illnesses and were matched by age and sex. Exclusion criteria included a history of hyperkalemia within the past three months, heart failure, pregnancy, or any condition contraindicating cardiopulmonary exercise testing. All participants underwent assessments within one week of enrollment, and written informed consent was obtained before participation."
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Blood collection
Other interventionErythrocyte osmotic deformability was evaluated via osmotic gradient ektacytometry.
Cardiopulmonary exercise testing (CPET)
Other interventionCardiopulmonary Exercise Testing (CPET) is a non-invasive assessment that evaluates the integrated function of the cardiovascular, pulmonary, and muscular systems during exercise.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ESRD2 interventions
Group B: Health control2 interventions
Trial outcomes
Primary outcomes
1
Deformability of erythrocytes
Deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.
Time frame
Data collection was completed within one week of participant enrollment2
Aggregation of erythrocytes
Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.
Time frame
Data collection was completed within one week of participant enrollment3
Cardiopulmonary fitness
ESRD patients performed cardiopulmonary exercise testing (CPET) to assess their aerobic capacity. CPET composed of continuous workload increment of 10 W/min until exhaustion (usually within 8-12 minutes). Oxygen consumption, carbon dioxide production, ventilation, respiratory rate would be recorded.
Time frame
Data collection was completed within one week of participant enrollmentSecondary outcomes
1
Quality of life in ESRD patients
The investigators would use a qusionnaire, The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36), to record and scale the qulaity of life in ESRD patients. The KDQOL-36 (Kidney Disease Quality of Life 36-Item Short Form Survey) measures the quality of life in kidney disease patients. It uses a score range from 0 to 100, where higher scores indicate better quality of life and lower scores indicate worse outcomes. Ensure to note this when reporting results to clarify that higher scores reflect fewer symptoms and better overall well-being.
Time frame
Data collection was completed within one week of participant enrollment2
Gardos function
Gardos channel activation leads to K⁺ efflux, followed by water loss, resulting in erythrocyte dehydration and increased fragility. Dysfunctional regulation of this channel contributes to impaired microcirculation and reduced oxygen delivery, exacerbating vascular complications in ESRD.
Time frame
Data collection was completed within one week of participant enrollmentSponsors and contacts
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Source ClinicalTrials.gov