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NCT Number: NCT05642156

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

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.

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Key information

Conditions

End Stage Kidney Disease 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Austria

Location status: Recruiting

Location contact

Alexander Kirsch, MD

CONTACT

[email protected]

+43316385 ext. 16023

About this study

A KDIGO (Kidney Disease: Improving Global Outcomes) controversies conference suggested that isolated ultrafiltration (iso-UF) may provide a benefit in hemodynamic stability, but whether this translates into benefits in hard outcomes is unclear and requires further research. So called-sequential dialysis, that is, isolated ultrafiltration followed by HD is commonly recommended, but evidence is very limited and mainly based on small older studies.

In conclusion, the supposed benefit for intradialytic hemodynamic stability attributed to isolated ultrafiltration compared to hemodialysis seems to be due to less pronounced changes in vascular resistance, but the reason for this discrepancy is unclear. Thus far, recommendations for using iso-UF to improve hemodynamic stability are mainly based on old studies which may not be applicable to modern technique used nowadays. Furthermore, there is no standardized approach on how to use isolated ultrafiltration, with neither a time period nor ultrafiltration rate recommended by the guidelines.

In this study, the investigators try to assess changes in peripheral resistance, osmolality, cardiac output, and cardiac power index and try to establish exploratory correlations to IDH episodes. Furthermore, the investigators want to assess the impact on dialysis quality by reduced time on dialysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

isolated Ultrafiltration (iso-UF)

Procedure

isolated Ultrafiltration

Primary outcomes

  1. Total peripheral resistance index (TPRI)

    Time frame: up to 8 weeks

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

Study contacts

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

Alexander H Kirsch

CONTACT

[email protected]

+43316385 ext. 16023

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: ISO-UF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Mar 4, 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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