Volume,Sodium and Blood Pressure Management in HD (VSBP)
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|ClinicalTrials.gov Identifier: NCT01766882|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : July 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Failure||Behavioral: Lower sodium intervention Other: Progressive Challenge to Post Dialysis Weight||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Fluid-Weight, Volume, Sodium, Blood Pressure Management in Hemodialysis by Limiting Intradialytic and Inter-dialytic Exposure to Sodium and Protocol-based Challenge of Post-dialysis Target Weight: A Pilot and Feasibility Trial|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments.
Behavioral: Lower sodium intervention
Other: Progressive Challenge to Post Dialysis Weight
1. Lower sodium intervention:
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).
No Intervention: Control
Usual care in addition to Blood pressure monitoring and and Hydration status monitoring
- Blood Pressure [ Time Frame: Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days ]Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)
- Post-dialysis Weight [ Time Frame: 12weeks ]Change in target post-dialysis weight
- Heart Rate [ Time Frame: 12 weeks ]Change in heart rate
- Plasma Volume [ Time Frame: 12 Weeks ]Slope of relative plasma volume monitoring
- Medication Use [ Time Frame: 12 Weeks ]Change in the utilization of antihypertensive medication ( number of medication and dose)
- Interdialytic Weight gain [ Time Frame: 12 Weeks ]Change in the mid-week interdialytic weight gain
- Intradialytic Hypotension [ Time Frame: 12 Weeks ]Frequency of intradialytic hypotension; defined as drop in systolic blood pressure associated with symptoms suggestive of low blood pressure such as lightheadedness, dizziness, sweating, etc., or decrease in intradialytic systolic blood pressure to less than 90 mmHg.
- Salt Appetite [ Time Frame: Baseline, 6 week and 12 week ]A measure of salt taste impairment and preference
- Thirst Score [ Time Frame: Baseline, 6 week, 12 weeks ]A measure of general thirst.
- Post-dialysis fatigue [ Time Frame: Baseline, 6 Weeks & 12 Weeks ]A measure of post-dialysis fatigue and recovery after each treatment session
- Routine Labs [ Time Frame: Baseline and 12Week ]o Routine labs including CBC, renal panel, hsCRP and brain natriuretic peptide (BNP). Interdialytic urine collection for residual renal function (urea and creatinine clearance) estimation will be made. Blood and urine samples will be archived for later analysis for biomarkers such as asymmetric dimethyl arginine (ADMA), plasma aldosterone, and urinary neutrophil gelatinase-associated lipocalin (NGAL), respectively
- True Dry Weight [ Time Frame: 12 weeks ]Time to achievement of true 'dry weight' (in the intervention arm only)
- Hydration Status [ Time Frame: 12 weeks ]Change in hydration status, as measured by BIA, using whole body and segmental techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766882
|United States, Michigan|
|University Dialysis Unit|
|Ann Arbor, Michigan, United States, 48104|
|University of Michigan Dialyisis Unit|
|Livonia, Michigan, United States, 48152|
|Principal Investigator:||Rajiv Saran, MD||University of Michigan|