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Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis (ISO-UF)

Primary Purpose

End Stage Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
isolated Ultrafiltration (iso-UF)
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease focused on measuring hemodialysis, ultrafiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sequential HD - Conventional HD

Conventional HD - Sequential HD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2022
Last Updated
December 5, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05642156
Brief Title
Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis
Acronym
ISO-UF
Official Title
Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
hemodialysis, ultrafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential HD - Conventional HD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional HD - Sequential HD
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
isolated Ultrafiltration (iso-UF)
Intervention Description
isolated Ultrafiltration
Primary Outcome Measure Information:
Title
Total peripheral resistance index (TPRI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander H Kirsch
Phone
+43316385
Ext
16023
Email
alexander.kirsch@medunigraz.at
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Kirsch, MD
Phone
+43316385
Ext
16023
Email
alexander.kirsch@medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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