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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • isolated Ultrafiltration (iso-UF)

    Procedure/Surgery

    isolated Ultrafiltration

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Sequential HD - Conventional HDActive comparator 1 intervention
Group B: Conventional HD - Sequential HDActive comparator 1 intervention

Trial outcomes

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.

Time frame
up to 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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