Rheological Functions of Erythrocyte in ESRD

NCT06868888 | Recruiting

• 1 other identifier: 202102279A3102
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

End-stage Renal Disease (ESRD)

Keywords

Hemodialysis; Aerobic capacity; Deformability; Erythrocyte

Outcome Measures

Primary Outcomes (3)

• 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.

  Data collection was completed within one week of participant enrollment

• Aggregation of erythrocytes

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

  Data collection was completed within one week of participant enrollment

• 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.

  Data collection was completed within one week of participant enrollment

Secondary Outcomes (2)

• Quality of life in ESRD patients

  Data collection was completed within one week of participant enrollment

• Gardos function

  Data collection was completed within one week of participant enrollment

Study Arms (2)

ESRD

ESRD patients under hemodialysis

Other: Blood collection; Other: Cardiopulmonary exercise testing (CPET)

Health control

Healthy sedentary volunteers

Other: Blood collection; Other: Cardiopulmonary exercise testing (CPET)

Interventions

Blood collection OTHER

Erythrocyte osmotic deformability was evaluated via osmotic gradient ektacytometry.

ESRD; Health control

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.

ESRD; Health control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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."

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection; Exercise Test

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Central Study Contacts

Jong-Shyan Wang, PhD

CONTACT

+886-3-2118800 Ext. 5748; s5492@mail.cgu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: August 24, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 26, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)