Effect of Sodium and UF Profiling on Dialysis
Effect of Sodium and Ultrafiltration Profiling on Hemodynamic Stability, Interdialytic Weight Gain, and Intradialytic Complications.
1 other identifier
observational
30
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the effects of sodium and UF profiling on hemodynamic stability, interdialytic weight gain, and intradialytic complications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2024
CompletedJanuary 19, 2024
January 1, 2024
6 months
September 18, 2023
January 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
systolic and diastolic blood pressure
The primary outcome is systolic blood pressure (80 \_130)mmhg and diastolic blood pressure within range (60\_80)mmhg, A blood pressure within this range is considered indicative of a better health outcome for the purposes of our research
2 weeks
Dialysis symptoms index
The Dialysis Symptom Index is a validated instrument to assess CKD-related unpleasant symptoms, and it is comprised of 30 questions about the presence of specifc symptoms For each question querying presence vs. absence of a specifc symptom, symptom severity is assessed using a five-point Likert scale, with each response ranging from 0 to 4 (i.e., a response of "0" indicates "no," whereas a response of "4" indicates "yes: very much"). The minimum-maxi- mum Dialysis Symptom Index score ranges from 0 to 120,with higher scores indicating worse outcome
2 weeks
Interventions
Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session
Eligibility Criteria
End-stage renal disease on regular HD
You may qualify if:
- End-stage renal disease patients.
- Patients on regular hemodialysis
You may not qualify if:
- Patients who refuse to contribute in this study.
- Hemodynamically unstable patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Coli L, La Manna G, Dalmastri V, De Pascalis A, Pace G, Santese G, Stefanio C, Ursino M, Zaca F, Stefoni S. Evidence of profiled hemodialysis efficacy in the treatment of intradialytic hypotension. Int J Artif Organs. 1998 Jul;21(7):398-402.
PMID: 9745994BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
youssef Saleh
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MA Researcher
Study Record Dates
First Submitted
September 18, 2023
First Posted
January 19, 2024
Study Start
January 15, 2024
Primary Completion
June 28, 2024
Study Completion
August 28, 2024
Last Updated
January 19, 2024
Record last verified: 2024-01