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Treatment Modification to Reduce Symptom Burden in Hemodialysis

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment modification

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hemodialysis patient
transplant ineligible

Exclusion Criteria:

dementia
unable to answer questionnaires for any reason

Sites / Locations

The Rogosin Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment modification

Usual care

Arm Description

Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.

Patients will receive the usual hemodialysis care with no modifications

Outcomes

Primary Outcome Measures

Number of Participants Recruited, Consented, Randomized and Completed

Secondary Outcome Measures

Symptom Burden

Number of symptoms in past week as measured by the Dialysis Symptom Index

Full Information

NCT ID

NCT01775800

First Posted

January 16, 2013

Last Updated

September 25, 2018

Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT01775800

Brief Title

Treatment Modification to Reduce Symptom Burden in Hemodialysis

Official Title

Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment modification

Arm Type

Experimental

Arm Description

Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Patients will receive the usual hemodialysis care with no modifications

Intervention Type

Other

Intervention Name(s)

Treatment modification

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Symptom Burden

Description

Number of symptoms in past week as measured by the Dialysis Symptom Index

Time Frame

Baseline and 6 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hemodialysis patient transplant ineligible Exclusion Criteria: dementia unable to answer questionnaires for any reason

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathaniel Berman, M.D.

Organizational Affiliation

The Rogosin Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rogosin Institute

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27139523

Citation

Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338.

Results Reference

result

Learn more about this trial

Treatment Modification to Reduce Symptom Burden in Hemodialysis

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