N/A N=16 Randomized Treatment

Treatment Modification to Reduce Symptom Burden in Hemodialysis

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT01775800 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants Recruited, Consented, Randomized and Completed — 51; 16; 16; 16 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment modification (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: The Rogosin Institute
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Recruited, Consented, Randomized and Completed	51; 16; 16; 16	—
SECONDARY Symptom Burden	9.00; 13.25; 11.00; 9.88	—

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.

Eligibility Criteria

Inclusion Criteria

hemodialysis patient
transplant ineligible

Exclusion Criteria

dementia
unable to answer questionnaires for any reason

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01775800). 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.