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

End Stage Renal Disease Requiring Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130089
• Other study ID #: 13-186
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: January 26, 2016
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardNew Zealand: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease Requiring Hemodialysis
• Kidney Failure, Chronic
• Weight Gain

Intervention

Behavioral:
• Intensive Tailored Education

Locations

Country	Name	City	State
New Zealand	Auckland Board of Health	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Percent Interdialytic Weight Gain		monthly for 7 months	No
Secondary	Thirst Intensity	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.	monthly for 7 months	No
Secondary	Sodium and Fluid Knowledge	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).	Monthly for 4 months	No