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Volume,Sodium and Blood Pressure Management in HD

NCT01766882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-07-15

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Renal Failure

Interventions

BEHAVIORAL

Lower sodium intervention

1\. Lower sodium intervention: 1. Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day (approximately \>180-200mmol/day in the average American diet). Sodium restriction will be implemented using intensive dietary counseling performed weekly by a registered study dietitian using the motivational interviewing technique. 2. Lower dialysate sodium at 137 mmol/L, if perchance a different concentration of dialysate is used for the enrolled individual, although this is unlikely in both the UM associated units, where for some time now, dialysate concentration of 137 mmol/L is currently being used as standard practice. Investigators will ensure that this sodium concentration is indeed used for all study participants.

OTHER

Progressive Challenge to Post Dialysis Weight

The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm. To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session. In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).

Sponsors & Collaborators

Principal Investigators

  • Rajiv Saran, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766882 on ClinicalTrials.gov