Treatment Modification to Reduce Symptom Burden in Hemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Rogosin Institute
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01775800
First received: January 16, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Other: Treatment modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

Resource links provided by NLM:


Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Symptoms and quality of life as measured by the Short Form-36 and Dialysis Symptom Index


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment modification
Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.
Other: Treatment modification
No Intervention: Usual care
Patients will receive the usual hemodialysis care with no modifications

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemodialysis patient
  • transplant ineligible

Exclusion Criteria:

  • dementia
  • unable to answer questionnaires for any reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775800

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Nathaniel Berman, M.D.    212-746-9766    nab2009@nyp.org   
Principal Investigator: Nathaniel Berman, M.D.         
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nathaniel Berman, M.D. The Rogosin Institute
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01775800     History of Changes
Other Study ID Numbers: 1207012494
Study First Received: January 16, 2013
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014