Clinical trial NCT06868888: Rheological Functions of Erythrocyte in ESRD
Official title: The Effect of Osmotic Stress in Erythrocyte Rheology in ESRD Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End-stage Renal Disease (ESRD)
Keywords: Hemodialysis
Aerobic capacity
Deformability
Erythrocyte
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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."

Brief summary: 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

Detailed description: End-stage renal disease (ESRD) profoundly alters osmotic homeostasis, disrupting erythrocyte deformability and impairing microcirculatory dynamics, ultimately compromising oxygen delivery to tissues. Persistent oxidative stress, hyperosmotic fluctuations, and accumulation of uremic toxins collectively modulate ion channel activity, particularly by stimulating cation influx and perturbing calcium regulation. These disruptions accelerate erythrocyte aging and promote eryptosis, a programmed form of red blood cell death. Furthermore, dysregulation of the Gardos channel exacerbates potassium efflux, leading to excessive cell dehydration, increased blood viscosity, and further deterioration of vascular integrity. Given the pivotal role of erythrocyte flexibility in oxygen transport efficiency, impairments in osmotic deformability may contribute to the reduced aerobic capacity frequently observed in ESRD patients. This study aims to elucidate the interplay between erythrocyte biomechanical properties and cardiopulmonary fitness in this population, shedding light on potential therapeutic targets to mitigate microvascular dysfunction.

Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis and medication at least for 6 weeks
* Kt/V score \> 1.2

Exclusion Criteria:

* Under 20 years-old
* Hyperkalemia occurs within 3 month
* Having orthopedic or muscular diseases
* Other concerned medical, psychological or physiological diseases
* Pregnancy
* Other exercise contraindications

Primary outcomes:
measure: Deformability of erythrocytes
timeFrame: Data collection was completed within one week of participant enrollment
measure: Aggregation of erythrocytes
timeFrame: Data collection was completed within one week of participant enrollment
measure: Cardiopulmonary fitness
timeFrame: Data collection was completed within one week of participant enrollment
Secondary outcomes:
measure: Quality of life in ESRD patients
timeFrame: Data collection was completed within one week of participant enrollment
measure: Gardos function
timeFrame: Data collection was completed within one week of participant enrollment
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: