Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000988257
Ethics application status
Not required
Date submitted
7/06/2018
Date registered
13/06/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
15/05/2019
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Intradialytic Hypertension Management in Adults
Scientific title
Observational study of individualised dialysate sodium in adult haemodialysis patients and its effect on the occurrence of intradialytic hypertension
Secondary ID [1] 295134 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 308228 0
Haemodialysis 308230 0
Condition category
Condition code
Renal and Urogenital 307256 307256 0 0
Kidney disease
Cardiovascular 307257 307257 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adjustment of dialysate sodium concentration during haemodialysis within the range 135 to 145mmol/L to achieve net zero diffusive sodium flux as part of standard local clinical practice in patients receiving haemodialysis that experience intradialytic hypertension. The sodium flux will be determined by simultaneous sampling of pre and post dialyser blood, with pre and post dialyser dialysate sampling for confirmation. The initial dialysate sodium will be set at 140mmol/L and then adjusted iteratively at 3 consecutive dialysis sessions then continued indefinitely at that concentration. Patients will be observed for 2 months following the assessment of dialysate sodium flux, whether or not this assessment results in a change in dialysate sodium.
Adjustment will be according to the formula
New dialysate sodium = [Current dialysate Na] + ([Na]arterial - [Na]venous)
Intervention code [1] 301461 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306208 0
Presence of intradialytic hypertension. This will be assessed by query of the electronic medical record 2 months after patients undergo assessment of dialysate sodium flux, whether or not this assessment has resulted in a change in the dialysate sodium concentration.
Timepoint [1] 306208 0
Two months after the assessment of dialysate sodium flux, whether or not this assessment has resulted in a change in dialysate sodium.
Secondary outcome [1] 347880 0
Thirst by use of a Likert scale administered prior to assessment of dialysate sodium flux and again 1 month later.
Timepoint [1] 347880 0
1 month after assessment of dialysate sodium flux

Eligibility
Key inclusion criteria
Patients with a median rise in BP of > 10 mmHg during dialysis over the preceding 2 week period AND an average pre-dialysis systolic BP >115 mmHg.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an average pre-dialysis systolic BP <=115 mmHg over the preceding 2 weeks.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics (relative frequency of intradialytic hypertension in patients before and after alteration of their dialysate sodium).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Treatment did not appear to have any effect on intradialytic hypertension so intervention was no longer offered to patients.
Date of first participant enrolment
Anticipated
18/06/2018
Actual
27/08/2018
Date of last participant enrolment
Anticipated
Actual
1/01/2019
Date of last data collection
Anticipated
23/05/2019
Actual
17/05/2019
Sample size
Target
15
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 11106 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 22919 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 299726 0
Hospital
Name [1] 299726 0
The Canberra Hospital
Country [1] 299726 0
Australia
Primary sponsor type
Individual
Name
Richard Singer
Address
Renal Unit
The Canberra Hospital
PO Box 11
ACT 2606
Country
Australia
Secondary sponsor category [1] 299060 0
None
Name [1] 299060 0
Address [1] 299060 0
Country [1] 299060 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
A rise in systolic blood pressure at the end of dialysis treatment compared to the beginning is associated with increased mortality during follow-up. This observational study aimed to see whether adjusting the dialysate sodium such that it matched the patient sodium helped to prevent significant rises in blood pressure during treatment, without causing undesirable falls in blood pressure. Matching of patient and dialysate sodium will be accomplished by adjusting the dialysate sodium so that the blood sodium concentration leaving the patient to go through the dialyser is the same as that re-entering the patient after its passage through the dialyser. Our hypothesis is that individualising the dialysate sodium in this way will reduce blood pressure problems during the dialysis treatment and may improve thirst.
Trial website
Trial related presentations / publications
Public notes
This observational study was assessed by the ACT Health Ethics Committee and determined to be a QA project that did not require ethics approval. Reference was ETHLR.18.005

Contacts
Principal investigator
Name 84222 0
Dr Richard Singer
Address 84222 0
Renal Unit
The Canberra Hospital
PO Box 11
Woden, ACT 2606
Country 84222 0
Australia
Phone 84222 0
+61262442222
Fax 84222 0
Email 84222 0
richard.singer@act.gov.au
Contact person for public queries
Name 84223 0
Dr Richard Singer
Address 84223 0
Renal Unit
The Canberra Hospital
PO Box 11
Woden, ACT 2606
Country 84223 0
Australia
Phone 84223 0
+61262442222
Fax 84223 0
Email 84223 0
richard.singer@act.gov.au
Contact person for scientific queries
Name 84224 0
Dr Richard Singer
Address 84224 0
Renal Unit
The Canberra Hospital
PO Box 11
Woden, ACT 2606
Country 84224 0
Australia
Phone 84224 0
+61262442222
Fax 84224 0
Email 84224 0
richard.singer@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Do not have permission for this from the applicable ethics committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Intradialytic hypertension was identified in 14 pa... [More Details]

Documents added automatically
No additional documents have been identified.