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The Danish Symptomburden Study Among Patients With Advanced Kidney Disease

NCT06019871 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 341

Last updated 2023-09-13

No results posted yet for this study

Summary

Patients with chronic kidney disease stage five have a high symptom burden regardless of whether they are treated with dialysis or without dialysis, a conservative kidney management pathway (CKM). Previously, there has not been a validated tool in Danish to collect information about symptoms. The Integrated Palliative Outcome Scale Renal (IPOS-Renal) has now been validated and translated into Danish. IPOS-Renal aims to identify symptoms among patients with chronic kidney disease stage five.

The purpose of the study is to investigate whether there is a correlation between treatment - dialysis (haemodialysis or peritoneal dialysis) or CKM for patients \>75 years of age with chronic kidney disease stage V and their symptom burden measured with IPOS-Renal. In addition, it is investigated whether there is a correlation between treatment - dialysis or CKM for patients \>75 years of age with chronic kidney disease stage V and their mortality.

The study will be conducted as an observational prospective cohort study over a two-year period, and based on a power calculation, it is expected to include 341 patients with data originating from 11 hospitals in Denmark. Comparison of change in symptom burden over time measured by IPOS-Renal for the two forms of treatment will be examined as continuous data, and then the t-test or Mann-Whitney test will be used. A cox proportional hazard regression analysis will be used to examine mortality for patients in dialysis treatment and patients on CKM pathway.

Conditions

  • Chronic Kidney Diseases

Interventions

PROCEDURE

Dialysis

Patients who have decided for dialysis either center haemo-dialysis or peritoneal dialysis

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jeanette Finderup · Aarhus University Hospital

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019871 on ClinicalTrials.gov