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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
Sponsor:
Information provided by (Responsible Party):
Renal Research Institute

Brief Summary:

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

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Interdialytic weight gain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Pre and post dialysis blood pressure levels. [ Time Frame: 12 weeks ]
  2. Intradialytic events. [ Time Frame: 12 weeks ]
  3. Thirst levels [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regimen.
  • Willing and able to provide written, signed informed consent after the nature of the study has been explained.
  • Willing and able to comply with all study procedures.
  • Age ≥18 years.

Exclusion Criteria:

  • Diabetes mellitus
  • Considerable residual renal function (diuresis > 500 mL/day)
  • Simultaneous participation in another clinical study except observational trials
  • Any psychological condition which could interfere with the patient's ability to comply with the study protocol
  • Expectation that native kidney function will recover
  • Impossibility to perform a blood pressure measurement on the upper limb
  • Unable to verbally communicate in English
  • Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
  • Life expectancy < 6 months

Information from the National Library of Medicine

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


Locations
United States, New York
Yorkville Dialysis Center
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Investigators
Principal Investigator: Peter Kotanko, MD Renal Research Institute

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT01168947     History of Changes
Other Study ID Numbers: 052-10
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Renal Research Institute:
sodium
hypertension
fluid overload
hemodialysis
dialysate
interdialytic weight gain
intradialytic hypotension

Additional relevant MeSH terms:
Hypertension
Weight Gain
Vascular Diseases
Cardiovascular Diseases
Body Weight Changes
Body Weight
Signs and Symptoms