Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain
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|ClinicalTrials.gov Identifier: NCT01168947|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : April 12, 2017
Sodium loading during hemodialysis treatment is common and may contribute to increased interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9% sodium chloride) is one of the factors that may cause sodium loading. During each hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow for removal of the equivalent amount of sodium.
Switching to a non sodium-containing solution for the priming and rinsing of the extracorporeal circuit can contribute to increased sodium removal during the dialysis treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood pressure control.
|Condition or disease||Intervention/treatment||Phase|
|Fluid Overload and Hypertension in Hemodialysis Patients||Other: 5% dextrose solution||Not Applicable|
This 12 week study consists of 3 phases:
Phase 1 (4 weeks): Observation only. Standard priming/rinsing procedure with isotonic saline Phase 2 (4 weeks): Intervention. Switch to a 5% dextrose solution for priming/rinsing procedure Phase 3 (4 weeks): Switch back to standard priming/rinsing procedure with isotonic saline During the study, blood pressures will be measured in a standardized manner at 2 week intervals, a thirst questionnaire will be completed at the end of each phase, and interdialytic weight gain, in-center pre/post-HD blood pressure and intradialytic symptoms will be recorded, apart for routinely measured parameters.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Sodium Concentration of Priming and Rinsing Fluids on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients: a Prospective Pilot Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: 5% dextrose
5% dextrose rinsing fluid
Other: 5% dextrose solution
The extracorporeal circuit of the dialysis machine will be primed and rinsed with a 5% dextrose solution instead of 0.9% saline.
- Interdialytic weight gain [ Time Frame: 12 weeks ]
- Pre and post dialysis blood pressure levels. [ Time Frame: 12 weeks ]
- Intradialytic events. [ Time Frame: 12 weeks ]
- Thirst levels [ Time Frame: 12 weeks ]
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): NCT01168947
|United States, New York|
|Yorkville Dialysis Center|
|New York, New York, United States, 10128|
|Principal Investigator:||Peter Kotanko, MD||Renal Research Institute|