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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
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: Treatment modification Not Applicable

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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
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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



Primary Outcome Measures :
  1. Number of Participants Recruited, Consented, Randomized and Completed [ Time Frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months ]

Secondary Outcome Measures :
  1. Symptom Burden [ Time Frame: Baseline and 6 weeks ]
    Number of symptoms in past week as measured by the Dialysis Symptom Index



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
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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
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Principal Investigator: Nathaniel Berman, M.D. The Rogosin Institute

Publications of Results:
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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
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: September 2018

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