N/A
Completed N=220
Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients
Source: ClinicalTrials.gov NCT00692419 ↗Enrolled (actual)
220
Serious AEs
15.5%
Results posted
Nov 2014
Primary outcomePrimary: Change in Pain, Sexual Dysfunction, and Depression Symptoms — -3.12; -3.7; 0.62; 0.71 units on a scale
Summary
This study is seeking to identify the most effective strategy to manage pain, sexual dysfunction, and depression in patients receiving chronic hemodialysis therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain, Sexual Dysfunction, and Depression Symptoms |
-3.12; -3.7; 0.62; 0.71; -1.99; -2.29 | — |
Eligibility Criteria
Inclusion Criteria
- Our target population is male and female hemodialysis patients age 18 years or greater who are English speakers.
Exclusion Criteria
- We will exclude children because they comprise a minority of the dialysis population and their enrollment would require an adult decision maker's consent.
- We will exclude patients who are significantly cognitively impaired and hence, unable to comprehend study surveys.
- Cognitive function will be assessed at baseline using the mini-Cog, a validated measure of cognitive capacity that we have used previously, and patients with scores <3 will be excluded.
- Based on our prior studies, we estimate that approximately 5% of patients will be excluded based on this criterion.
- Similarly, non-English speakers will be excluded.
- Finally, patients undergoing active work-up for living donor kidney transplant, and/or considering transfer to peritoneal dialysis will be excluded as they are less likely to remain on hemodialysis for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT00692419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.