The Danish Symptomburden Study Among Patients With Advanced Kidney Disease

NCT06019871 | Unknown

• 1 other identifier: 15032023
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• IPOS score

  A score between zero and 40. A high score means a high symptom burden

  after six months, after 12 months, after 18 months and after 24 months

Secondary Outcomes (1)

• Mortality

  For two years

Study Arms (2)

Decided for conservative kidney management

Patient with advanced kidney disease and decided for conservative kidney management

Decided for dialysis

Patient with advanced kidney disease and decided for dialysis

Procedure: Dialysis

Interventions

Dialysis PROCEDURE

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

Decided for dialysis

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be included right after they have made their decision about treatment - dialysis (haemodialysis or peritoneal dialysis) or CKM pathway. In addition, patients must meet inclusion criteria. The patients will be observed for at least two years or until death. The study is expected to start on 15.03.2023, and it is expected to be completed on 15.09.2025.

You may qualify if:

• Patients with chronic kidney disease stage V
• Patients \>75 years
• Patients who have decided on future treatment with either dialysis (haemodialysis or peritoneal dialysis) or a CKM pathway

You may not qualify if:

• Patients eligible for kidney transplantation
• Patients who have decided on home haemodialysis
• Patients who do not wish to participate in the study
• Patients who are unable to participate in the study due to cognitive impairment

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Department of Renal Medicine

Aarhus N, Denmark

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Jeanette Finderup

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finderup

CONTACT

004578452525; jeajee@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: August 31, 2023
• Study Start: March 15, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)