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NCT Number: NCT06868888

Rheological Functions of Erythrocyte in ESRD

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

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Key information

Conditions

End-stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung University

Taoyuan, 333, Taiwan

Location status: Recruiting

Location contact

Jong-Shyan Wang, PhD

CONTACT

[email protected]

+886-3-2118800 Ext. 5748

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

Erythrocyte osmotic deformability was evaluated via osmotic gradient ektacytometry.

Cardiopulmonary Exercise Testing (CPET)

Other

Cardiopulmonary Exercise Testing (CPET) is a non-invasive assessment that evaluates the integrated function of the cardiovascular, pulmonary, and muscular systems during exercise.

Primary outcomes

  1. Deformability of erythrocytes

    Time frame: Data collection was completed within one week of participant enrollment

    Deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.

  2. Aggregation of erythrocytes

    Time frame: Data collection was completed within one week of participant enrollment

    Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.

  3. Cardiopulmonary fitness

    Time frame: Data collection was completed within one week of participant enrollment

    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.

Secondary outcomes

  1. Quality of life in ESRD patients

    Time frame: Data collection was completed within one week of participant enrollment

    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.

  2. Gardos function

    Time frame: Data collection was completed within one week of participant enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jong-Shyan Wang, PhD

CONTACT

[email protected]

+886-3-2118800 Ext. 5748

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Effect of Osmotic Stress in Erythrocyte Rheology in ESRD Patients

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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