Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis

NCT05642156 | Recruiting

• 1 other identifier: ISO-UF
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Patients treated with hemodialysis (HD) bear increased risk of cardiovascular events, which results in high morbidity and mortality among this cohort of patients. Intradialytic hypotension (IDH), which is an independent risk factor for mortality, occurs in up to 20% of hemodialysis session and may lead to myocardial stunning and cerebral ischemia resulting in increased white matter lesions, gastrointestinal ischemia and shunt vessel thrombosis. Due to the deleterious effects of IDH during HD, preventive measurements such as limiting interdialytic weight gain are recommended, but frequently fluid and salt restriction are not adhered to, thus increasing dialysis time or frequency of treatments is a common strategy in those patients.

Conditions

End Stage Kidney Disease

Keywords

hemodialysis; ultrafiltration

Outcome Measures

Primary Outcomes (1)

• Total peripheral resistance index (TPRI)

  Absolute change of TPRI (expressed as dyn\*sec/cm\*m2) in each individual session from baseline to the nadir.

  up to 8 weeks

Study Arms (2)

Sequential HD - Conventional HD

ACTIVE COMPARATOR

In sequence A patients will be treated with sequential HD first, for a total of 8 session and then switched to a conventional HD schedule for another 8 sessions.

Procedure: isolated Ultrafiltration (iso-UF)

Conventional HD - Sequential HD

ACTIVE COMPARATOR

In sequence A patients will be treated with conventional HD first, for a total of 8 session and then switched to a sequential HD schedule for another 8 sessions.

Procedure: isolated Ultrafiltration (iso-UF)

Interventions

isolated Ultrafiltration (iso-UF) PROCEDURE

isolated Ultrafiltration

Conventional HD - Sequential HD; Sequential HD - Conventional HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent of the participant after being informed
• At least 18 years of age
• End stage kidney disease patient undergoing hemodialysis
• Dry weight stable for a minimum of one month
• Interdialytic weight gain of \>2 liters in the short interdialytic interval

You may not qualify if:

• No informed consent was obtained
• Patients with a pacemaker or implanted medical device that prevents compliance with study regulations
• Patients treated with hemodiafiltration
• Patients treated with medium cut-off membranes (Theranova, Baxter)
• Patients with recurrent severe hyperkalemia after the short interdialytic interval (K+ concentration \> 6.0 mmol/L, requiring more than 2 hours of dialysis to ameliorate the post-dialytic shift from other compartments.
• Women of childbearing age not using contraception

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Austria

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Central Study Contacts

Alexander H Kirsch

CONTACT

+43316385; alexander.kirsch@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: November 2, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)