Treatment Modification to Reduce Symptom Burden in Hemodialysis

September 25, 2018 updated by: The Rogosin Institute

Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • The Rogosin Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hemodialysis patient
  • transplant ineligible

Exclusion Criteria:

  • dementia
  • unable to answer questionnaires for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Recruited, Consented, Randomized and Completed
Time Frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months
Each participant was assessed for 6 weeks; total recruitment period was 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Burden
Time Frame: Baseline and 6 weeks
Number of symptoms in past week as measured by the Dialysis Symptom Index
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207012494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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