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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02130089




Registration number
NCT02130089
Ethics application status
Date submitted
28/04/2014
Date registered
5/05/2014
Date last updated
27/01/2016

Titles & IDs
Public title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Scientific title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Secondary ID [1] 0 0
13-186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease Requiring Hemodialysis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Intensive Tailored Education

Other: All patients - Intensive tailored education


Behaviour: Intensive Tailored Education


Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Percent Interdialytic Weight Gain
Timepoint [1] 0 0
monthly for 7 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
monthly for 7 months
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Monthly for 4 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Academy of Nutrition and Dietetics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02130089
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra McLellan
Address 0 0
Auckland Board of Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications