Volume,Sodium and Blood Pressure Management in HD
Completed · Not applicable
Conditions studied: End Stage Renal Failure
In brief
The purpose of this study to conduct a pilot, randomized trial in stable HD patients to evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight, combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure on hydration/volume status and blood pressure (BP) control.
Key facts
- Study ID
- NCT01766882
- Run by
- University of Michigan
- People needed
- 50
- Starts
- 2012-09-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-07-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Stable adult HD patient (age 18-85 years)
- Usual in-center pre-dialysis systolic blood pressure of ≥130mmHg. For this purpose mean of pre-dialysis sitting blood pressures for the past one month prior to randomization will be applied for evaluation of inclusion criteria.
- Able and willing to adhere to study protocol
You may not qualify if…
- Recent acute illness (≤1month)
- Recent hospitalization (≤1month)
- Any psychological condition that could interfere with compliance with study protocol.
- Amputation of both lower limbs (due to interference with electric current for BIA measurement)
- Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings), if their presence interfere with appropriate measurements. In such patients consideration will be given to only doing the calf-BIA measurements and not the total body, at the discretion of the investigators.
- Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Pregnancy or lactation (pregnancy test will be applied only if the patient is in the reproductive age range).
- Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study
Where it is running
- University Dialysis Unit — Ann Arbor, Michigan, United States
- University of Michigan Dialyisis Unit — Livonia, Michigan, United States
Full record on ClinicalTrials.gov
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