Treatment Modification to Reduce Symptom Burden in Hemodialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: Treatment modification

• Registration Number: NCT01775800
• Lead Sponsor: The Rogosin Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2018-09
• Results First Submitted: 2018-09-25
• Results First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• hemodialysis patient
• transplant ineligible

Exclusion Criteria

• dementia
• unable to answer questionnaires for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment modification	Treatment modification	Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.

Primary Outcome Measures

Name	Time	Method
Number of Participants Recruited, Consented, Randomized and Completed	Each participant was assessed for 6 weeks; total recruitment period was 15 months

Secondary Outcome Measures

Name	Time	Method
Symptom Burden	Baseline and 6 weeks	Number of symptoms in past week as measured by the Dialysis Symptom Index

Trial Locations

Locations (1)

The Rogosin Institute; 🇺🇸 New York, New York, United States