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Clinical Trials/NCT01775800
NCT01775800CompletedNot Applicable

Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

The Rogosin Institute1 site in 1 country16 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Number of Participants Recruited, Consented, Randomized and Completed

Study Overview

Brief Summary

Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • hemodialysis patient
  • transplant ineligible

Exclusion Criteria

  • unable to answer questionnaires for any reason

Outcomes

Primary Outcomes

Number of Participants Recruited, Consented, Randomized and Completed

Time Frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months

Secondary Outcomes

  • Symptom Burden(Baseline and 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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