Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Description

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.

Eligibility

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

Study details

End Stage Kidney Disease

NCT05642156

Medical University of Graz

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.