End Stage Renal Disease
Conditions
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.
Interventions
OTHERTreatment modification
Sponsors
Weill Medical College of Cornell University
The Rogosin Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* hemodialysis patient * transplant ineligible
Exclusion criteria
* dementia * unable to answer questionnaires for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Recruited, Consented, Randomized and Completed | Each participant was assessed for 6 weeks; total recruitment period was 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Burden | Baseline and 6 weeks | Number of symptoms in past week as measured by the Dialysis Symptom Index |
Countries
United States
Participant flow
Recruitment details
There were 300 dialysis patients screened. 51 were eligible to participate and 16 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Modification Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus | 8 |
| Usual Care Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Treatment Modification | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 72.38 years STANDARD_DEVIATION 10.29 | 69.50 years STANDARD_DEVIATION 16.59 | 70.94 years STANDARD_DEVIATION 13.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Participants Recruited, Consented, Randomized and Completed
Time frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months
Population: This number represents the entire dialysis population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dialysis Patients | Number of Participants Recruited, Consented, Randomized and Completed | Transplant ineligible | 51 Participants |
| Dialysis Patients | Number of Participants Recruited, Consented, Randomized and Completed | Consented | 16 Participants |
| Dialysis Patients | Number of Participants Recruited, Consented, Randomized and Completed | Data collected | 16 Participants |
| Dialysis Patients | Number of Participants Recruited, Consented, Randomized and Completed | Completed | 16 Participants |
Secondary
Symptom Burden
Number of symptoms in past week as measured by the Dialysis Symptom Index
Time frame: Baseline and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dialysis Patients | Symptom Burden | 6 weeks | 11.00 symptoms | Standard Deviation 6.97 |
| Dialysis Patients | Symptom Burden | Baseline | 9.00 symptoms | Standard Deviation 5.45 |
| Usual Care | Symptom Burden | Baseline | 13.25 symptoms | Standard Deviation 6.88 |
| Usual Care | Symptom Burden | 6 weeks | 9.88 symptoms | Standard Deviation 4.45 |