Skip to main content
OpenTrials
Completed

NCT Number: NCT02130089

Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?

The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Requiring Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auckland Board of Health

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
  • Able to sign the locally approved informed consent
  • Willing to receive dietitian education on sodium and fluid control during normal dialysis time
  • Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years

Exclusion criteria

  • On hospice or international equivalent
  • Receiving corticosteroid treatment
  • Less than 18 years old
  • On interdialytic parenteral nutrition
  • Transfer to another facility expected within 3 months
  • Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool

Treatment and study plan

Intensive Tailored Education

Behavioral

Primary outcomes

  1. Average Percent Interdialytic Weight Gain

    Time frame: monthly for 7 months

Secondary outcomes

  1. Thirst Intensity

    Time frame: monthly for 7 months

    will be measured by a 100 mm Visual Analog Scale. Patients are asked to mark the point on the VAS which represents their work thirst since the last dialysis. Zero is considered no thirst and 100 is extremely thirsty. This tool has been shown to correlate to the Thirst Distress tool developed by Welsh in 2002.

  2. Sodium and Fluid Knowledge

    Time frame: Monthly for 4 months

    Will be assessed using the sodium questions of the tool created by Kim (Korean J Nutr 2001), as modified by Park (J Ren Nutr 2008).

Sponsors and collaborators

Lead sponsor

Academy of Nutrition and Dietetics

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 5, 2014
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.