Treatment Modification to Reduce Symptom Burden in Hemodialysis

NCT ID: NCT01775800

Last Updated: 2018-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment modification

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

Group Type EXPERIMENTAL

Treatment modification

Intervention Type OTHER

Usual care

Patients will receive the usual hemodialysis care with no modifications

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treatment modification

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* hemodialysis patient
* transplant ineligible

Exclusion Criteria

* dementia
* unable to answer questionnaires for any reason
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

The Rogosin Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathaniel Berman, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

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The Rogosin Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27139523 (View on PubMed)

Other Identifiers

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1207012494

Identifier Type: -

Identifier Source: org_study_id

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