Expanded hemodialysis registry protocol in Colombia

Not Applicable

Completed

• Conditions: End stage renal disease with hemodialysis; Urological and Genital Diseases

• Registration Number: ISRCTN45211359
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32352233/ results on impact of medium cutoff (MCO) membranes on clinical outcomes and safety (added 28/03/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33176299/ results on impact of medium cutoff (MCO) membranes on patient-reported outcomes (added 28/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Study Completion: 2018-12-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 992

Inclusion Criteria

1. The subject or a legally authorized representative has signed the written informed consent form
2. The subject is = 18 years old
3. The subject has been diagnosed with CKD with more than 90 days in chronic hemodialysis
4. The subject has been receiving expanded hemodialysis treatment in a renal clinic of the RTS network with the Theranova® dialyzer
5. The subject has been undergoing a hemodialysis schedule at least 3 times per week and a minimum duration of 4 hours per session
6. The subject is being dialyzed in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI)

Exclusion Criteria

1. The subject has a life expectancy of no more than six months as determined by his/her attending physician
2. The subject has or had an active infection diagnosed in the past 4 weeks

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Effectiveness assessments:<br> 1. The rates of hospitalization and hospital days<br> 2. Mortality rates<br> 3. Rates of non-fatal cardiovascular events<br> Exported directly from the patient’s electronic medical record system; the follow-up is 1 year.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient-reported outcome measures: individual item scores and total scores for Dialysis Symptom Index (DSI) and quality of life (KDQOL-36™) and frequency of restless legs diagnosis<br> 2. Number of uses of phosphorus chelating agents and plasma phosphorus level<br> 3. ESA dose, type and route of administration and hemoglobin level<br> 4. Number of antihypertensive drugs and systolic and diastolic blood pressure<br> 5. Intake of tablets/pills per day and KDQOL-36™ Score<br> 6. Use of nutritional supplements and nutritional status<br> Exported directly from the patient’s electronic medical record system; the follow-up is 1 year.<br>