Treatment Modification to Reduce Symptom Burden in Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775800
• Other study ID #: 1207012494
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2018
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• hemodialysis patient

• transplant ineligible

Exclusion Criteria:

• dementia

• unable to answer questionnaires for any reason

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Treatment modification

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Rogosin Institute	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited, Consented, Randomized and Completed		Each participant was assessed for 6 weeks; total recruitment period was 15 months
Secondary	Symptom Burden	Number of symptoms in past week as measured by the Dialysis Symptom Index	Baseline and 6 weeks