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Treatment Modification to Reduce Symptom Burden in Hemodialysis

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ClinicalTrials.gov Identifier: NCT01775800
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
End Stage Renal Disease Other: Treatment modification

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Modification and Symptom Burden in High-Risk Dialysis Patients
Study Start Date : January 2013
Primary Completion Date : March 2015
Study Completion Date : March 2015
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. quality of life [ Time Frame: 6 weeks ]
    Symptoms and quality of life as measured by the Short Form-36 and Dialysis Symptom Index


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemodialysis patient
  • transplant ineligible

Exclusion Criteria:

  • dementia
  • unable to answer questionnaires for any reason
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775800


Locations
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nathaniel Berman, M.D. The Rogosin Institute
More Information

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01775800     History of Changes
Other Study ID Numbers: 1207012494
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

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