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Trial registered on ANZCTR

Registration number
Ethics application status
Not required
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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

Study type
Patient registry
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients with an average pre-dialysis systolic BP <=115 mmHg over the preceding 2 weeks.

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

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 299726 0
The Canberra Hospital
Address [1] 299726 0
77 Yamba Drive
Garran, ACT, 2605
Country [1] 299726 0
Primary sponsor type
Richard Singer
Renal Unit
The Canberra Hospital
PO Box 11
ACT 2606
Secondary sponsor category [1] 299060 0
Name [1] 299060 0
Address [1] 299060 0
Country [1] 299060 0

Ethics approval
Ethics application status
Not required

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

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
Phone 84222 0
Fax 84222 0
Email 84222 0
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
Phone 84223 0
Fax 84223 0
Email 84223 0
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
Phone 84224 0
Fax 84224 0
Email 84224 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 other documents available
Summary results
No Results