Somatic symptoms in patients with chronic kidney disease

Not Applicable

• Conditions: Chronic kidney disease (CKD) stages 2-4; Urological and Genital Diseases

• Registration Number: ISRCTN16137374
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36396319/ (added 18/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-18
• Last Update Posted: 8 January 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Current participant inclusion criteria as of 27/09/2023:
Inclusion criteria for the patient group:
1. Clinical diagnosis of CKD stages 2-4
2. Newly diagnosed with CKD
3. Age =18 years
4. Sufficient oral and written German language proficiency
5. Provision of written consent

Inclusion criteria for the healthy control group:
1. To be at least 18 years old (equivalent to the patient group)
2. Sufficient knowledge of the German language

1. Clinical diagnosis of CKD stages 2-4
2. Newly diagnosed with CKD
3. Age =18 years
4. Sufficient oral and written German language proficiency
5. Provision of written consent

Exclusion Criteria

Current participant exclusion criteria as of 27/09/2023:
Exclusion criteria for the patient group:
1. Acute severe somatic or psychiatric disease
2. Florid psychosis
3. Substance abuse disorder
4. Acute suicidality
5. Cognitive impairment
6. Planned dialysis within the next 6 months
7. Current dialysis
8. Dialysis in history longer than 3 months
9. Kidney transplantation
10. Life expectancy shorter than 6 months

Exclusion criteria for the healthy control group:
1. Existence of a chronic kidney disease
2. Cognitive impairment (equivalent to the patient group)
3. Diagnosis of psychosis, schizophrenia etc. (equivalent to the patient group)
4. Drug addiction (also equivalent to the patient group)
5. Acute suicidality

Previous participant exclusion criteria:
1. Acute severe somatic or psychiatric disease
2. Florid psychosis
3. Substance abuse disorder
4. Acute suicidality
5. Cognitive impairment
6. Planned dialysis within the next 6 months
7. Current dialysis
8. Dialysis in history longer than 3 months
9. Kidney transplantation
10. Life expectancy shorter than 6 months

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CKD-specific somatic symptom burden will be assessed with the CKD Symptom Burden Index (CKD-SBI) at baseline, after 6 and after 12 months.