Volume,Sodium and Blood Pressure Management in HD

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

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).

Trial Locations (2)

48104

University Dialysis Unit, Ann Arbor

48152

University of Michigan Dialyisis Unit, Livonia

All Listed Sponsors
collaborator

Renal Research Institute

OTHER

lead

University of Michigan

OTHER

NCT01766882 - Volume,Sodium and Blood Pressure Management in HD | Biotech Hunter | Biotech Hunter