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A retrospective comparison of two types of dialysis machine for dialysis patients

Effectiveness of expanded hemodialysis (HDx) in Colombia: A retrospective clinical outcomes study

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12403265
Enrollment
1250
Registered
2020-08-13
Start date
2020-08-01
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage renal disease (Hemodialysis patients) Urological and Genital Diseases Renal disease

Interventions

Patient Population: Prevalent HD patients will be entered into two cohorts and followed for 2 years Cohort 1: patients who receive treatment with HDx using Theranova dialyzers. These p

Sponsors

Renal Therapy Services
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. End stage renal disease 2. Prevalent HD patient defined as having received HD for 90 days or more at the time of the cohort’s inception (01 September 2017 through 30 November 2017) 3. Enrolled in the COREXH registry between 01 September 2017 and 30 November 2017, or were treated via conventional high-flux HD during the same time period at the same renal centers, and with the same model of dialysis care 4. Undergoing HD at least 3 times per week and a minimum duration of 4 hours per session 5. Received dialysis treatment in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI)

Exclusion criteria

Exclusion criteria: 1. High comorbidity measured as Charlson comorbidity Index > 8 and patients who were not expected to survive 6 months 2. Metastatic disease 3. Pregnancy 4. Younger than 18 years old

Design outcomes

Primary

MeasureTime frame
Measured using patient records at 2 year follow up: 1. Hospitalization events 2. Days spent in hospital

Secondary

MeasureTime frame
Measured using patient records at 2 year follow up: 1. Mortality 2. Medication consumption

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026