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Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01168947
First received: July 22, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 Intervention
Fluid Overload and Hypertension in Hemodialysis Patients.
Other: 5% dextrose solution

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • Interdialytic weight gain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre and post dialysis blood pressure levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Intradialytic events. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Thirst levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT01168947     History of Changes
Other Study ID Numbers: 052-10
Study First Received: July 22, 2010
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014