Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001236381
Ethics application status
Approved
Date submitted
7/08/2017
Date registered
24/08/2017
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of low dialysate sodium on interdialytic weight gain (IDWG) and hypertension in patients undergoing chronic intermittent haemodialysis – a prospective study in The Townsville Hospital and the North Ward haemodialysis units
Scientific title
Effect of low dialysate sodium on interdialytic weight gain (IDWG) and hypertension in patients undergoing chronic intermittent haemodialysis – a prospective study in The Townsville Hospital and the North Ward haemodialysis units
Secondary ID [1] 292608 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal failure 304286 0
Condition category
Condition code
Renal and Urogenital 303633 303633 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention phase: alteration of sodium bath concentration in dialyser from 140mEq/L to 136mEq/L

-Participants will be provided an information sheet explaining the intervention and purpose of the study
-Dialysis nurses (competent to deliver a dialysis service) will alter settings on the machine to allow change in sodium bath. Participants will otherwise undergo their normal dialysis treatment in the unit.
-Delivery of the intervention will take place at each dialysis session.
- The intervention will be performed at each dialysis session (three sessions per week) for a total of 8 weeks
- Initially the bath concentration will be decreased from 140mEq/l to 138mEq/l for 1 week (three treatment sessions) and then to 136mEq/l for the remainder of the data collection period
- The intervention will occur within the haemodialysis unit (Townsville Hospital; North Ward Satellite Clinic)

The intervention will be applied to all eligible participants
Participants will need to attend their usual planned haemodialysis treatment to receive the intervention.
Adherence:
-Dialysis nurses routinely call patients when they do not attend their planned haemodialysis treatment; social workers provide assistance for community-based transport for those who require it;
2. The 8 week control period will be performed prior to the 8 week intervention period for every participant.
Intervention code [1] 298821 0
Treatment: Other
Comparator / control treatment
Active Control: sodium bath concentration in dialyser remains at 140mEq/L

-Participants will be provided an information sheet explaining the intervention and purpose of the study
-Dialysis nurses (competent to deliver a dialysis service) will not change the usual sodium bath. Participants will undergo their normal dialysis treatment in the unit.
-Delivery of the intervention will take place at each dialysis session.
- The control phase will be performed at each dialysis session (three sessions per week) for a total of 8 weeks
- Sodium bath concentration remains unchanged for an 8 week period of observation
- The control phase will occur within the haemodialysis unit (Townsville Hospital; North Ward Satellite Clinic)

All eligible participants will undergo a 8 week period of observation with the usual dialysis regime
Participants will need to attend their usual planned haemodialysis treatment.
Control group
Active

Outcomes
Primary outcome [1] 302991 0
Proportion of participants with a reduction in interdialytic weight gain of at least 0.5kg after reduction in dialysate sodium (by 4mEq/L); assessed by weighing participant pre and post dialysis
Timepoint [1] 302991 0
8 weeks following intervention
Primary outcome [2] 303167 0
Proportion of participants with reduction in interdialytic hypertension of at least 10mmHg (systolic blood pressure), assessed by sphygomanometer prior to commencing dialysis
Timepoint [2] 303167 0
8 weeks
Secondary outcome [1] 337644 0
Incidence of number of hypotensive events (interdialytic and postdialytic); defined as SBP <100mmHg, per week; assessed by sphygomanometer during and immediately following dialysis
Timepoint [1] 337644 0
8 weeks
Secondary outcome [2] 338090 0
Incidence of post dialysis cramping (number of episodes per week), assessed by patient self-report
Timepoint [2] 338090 0
8 weeks
Secondary outcome [3] 338091 0
Incidence of intra- and post dialysis events of nausea (events per week), assessed by patient self-report
Timepoint [3] 338091 0
8 weeks
Secondary outcome [4] 338092 0
Incidence of headache during or following dialysis (episodes per week); assessed by patient self-report
Timepoint [4] 338092 0
8 weeks

Eligibility
Key inclusion criteria
1. Patients aged between 18 and 90 years
2. Patients on maintenance haemodialysis for at least 6 months
3. Patients with significant IDWG (2 kilogram or more) with or without associated uncontrolled hypertension
4. Patients who are medically stable with no other acute issues that can affect the study outcome
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have cardiac failure and cardiovascular compromise
2. Patients who are admitted to hospital for acute illness
3. Patients who are hyponatraemic (sodium <135)
3. Patients prone for hypotension
4. Patients who are pregnant
5. Patients who are homeless

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
If the true difference in the experimental and control means is 0.6, the study will need 44 subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05 (Sample size calculated using openepi version 3. The mean weight gain and SD for sample size calculations were based on the study by Mendoza JM, et al. Effect of Lowering Dialysate Sodium Concentration on Interdialytic Weight Gain and Blood Pressure in Patients undergoing Thrice-weekly In-Centre Nocturnal Hemodialysis: A Quality Improvement Study).

Continuous variables will be tested for normality. Based on the outcome of the test parametric students T test or non-parametric Mann-Whitney test will be carried out to determine the significant differences in weight gain. Paired tests will be carried out to determine differences in weight gain among the patients during and after the treatment. Categorical data will be analysed using the Chi-squared analysis. Bivariate analysis would be performed for determining the confounding factors. Where appropriate multivariate tests will be carried out, a p value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2017
Actual
Date of last participant enrolment
Anticipated
2/02/2018
Actual
Date of last data collection
Anticipated
30/03/2018
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8696 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 16808 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 297195 0
Hospital
Name [1] 297195 0
The Townsville Hospital
Country [1] 297195 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive
Douglas, QLD 4810
Country
Australia
Secondary sponsor category [1] 296204 0
None
Name [1] 296204 0
None
Address [1] 296204 0
None
Country [1] 296204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298351 0
Townsville Hospital and Health Service Human Research Ethcis Committee
Ethics committee address [1] 298351 0
100 Angus Smith Drive
Douglas, QLD 4810
Ethics committee country [1] 298351 0
Australia
Date submitted for ethics approval [1] 298351 0
13/09/2015
Approval date [1] 298351 0
25/10/2015
Ethics approval number [1] 298351 0
HREC/16/QTHS/200

Summary
Brief summary
Purpose of the research
Significant weight gain and poorly controlled blood pressure are commonly seen in patients with end stage renal disease on intermittent hemodialysis. There is evidence that these complications are due to not enough salt being removed from the body during hemodialysis. The hemodialysis machine currently uses a standard strength of sodium during each hemodialysis session. If this concentration is reduced, this may improve blood pressure control and decrease the amount of weight gained between dialysis sessions. The reason we are doing this research is to find out if the low sodium fluid is better than the regular concentration that is currently being used.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1950 1950 0 0
/AnzctrAttachments/373437-Informed Consent V1.4 11-05-17.docx (Participant information/consent)
Attachments [2] 1951 1951 0 0
/AnzctrAttachments/373437-16QTHS200_4 Approved.pdf (Ethics approval)
Attachments [3] 1952 1952 0 0
/AnzctrAttachments/373437-ResearchProtocolV1.411052017.docx (Protocol)

Contacts
Principal investigator
Name 76806 0
Dr Catherine Wilkinson
Address 76806 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4810
Country 76806 0
Australia
Phone 76806 0
+617 44331111
Fax 76806 0
Email 76806 0
[email protected]
Contact person for public queries
Name 76807 0
Dr Catherine Wilkinson
Address 76807 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4810
Country 76807 0
Australia
Phone 76807 0
+61 7 4433 1111
Fax 76807 0
Email 76807 0
[email protected]
Contact person for scientific queries
Name 76808 0
Dr Catherine Wilkinson
Address 76808 0
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4810
Country 76808 0
Australia
Phone 76808 0
+61 7 44331111
Fax 76808 0
Email 76808 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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