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Trial registered on ANZCTR


Registration number
ACTRN12614000929606
Ethics application status
Not yet submitted
Date submitted
8/08/2014
Date registered
29/08/2014
Date last updated
29/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood-pressure variability and hypertensive control in patients with renal failure - the potential for smoother and superior control of mean blood-pressure and episodic hypertension through higher-dose dialysis.
Scientific title
In dialysis patients, does higher-dose renal replacement provide better control of blood pressure when compared to standard dose therapy?
Secondary ID [1] 285134 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 292704 0
Dialysis 292705 0
Renal Failure 292706 0
Blood Pressure Variability 292707 0
Condition category
Condition code
Cardiovascular 293013 293013 0 0
Hypertension
Renal and Urogenital 293014 293014 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prevalent patients undergoing extended hours / home based therapy :
Haemodialysis (>6hour treatment at a frequency of alternate nightly or greater = >20hrs treatment/week) OR peritoneal dialysis (conventional ambulatory peritoneal dialysis or overnight automated peritoneal dialysis). Patients must be established on therapy for at least 3 months. Patients will be observed over one dialysis treatment and subsequent interdialytic period.
Intervention code [1] 289986 0
Not applicable
Comparator / control treatment
Standard conventional thrice weekly in-centre haemodialysis (<15hrs/week treatment time)
Control group
Active

Outcomes
Primary outcome [1] 292873 0
Systolic Hypertension as defined by SBP >160mmHg by brachial cuff measurement on the non-vascular access arm.
Timepoint [1] 292873 0
Assessed at incident treatment period through the Intra and Interdialytic timeframes. Intradialytic timepoints are pre & post dialysis, with hourly measures in-between. Interdialytic timepoints as assessed by ambulatory (brachial) monitoring at 30 minute daytime cycles and hourly overnight. Patients will be established on therapy for >3months at time of study. Patients will be observed over one dialysis treatment and subsequent interdialytic period (~44 hours)
Secondary outcome [1] 309848 0
Blood Pressure Variability as defined by standard deviation of the cumulative systolic pressure readings from noninvasive brachial cuff measures.
Timepoint [1] 309848 0
Assessed at incident treatment period through the Intra and Interdialytic timeframes. Intradialytic timepoints are pre & post dialysis, with hourly measures in-between. Interdialytic timepoints as assessed by ambulatory (brachial) monitoring at 30 minute daytime cycles and hourly overnight.Patients will be established on therapy for >3months at time of study. Patients will be observed over one dialysis treatment and subsequent interdialytic period (~44 hours)

Eligibility
Key inclusion criteria
End-stage renal disease requiring dialysis
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal replacement for <3 months

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 289743 0
Commercial sector/Industry
Name [1] 289743 0
Baxter Healthcare
Address [1] 289743 0
One Baxter Parkway
Deerfield, IL 60015-4625
Country [1] 289743 0
United States of America
Primary sponsor type
Hospital
Name
Alfred Health Renal Unit
Address
55 Commercial Road Melbourne, VICTORIA, Australia 3004
Country
Australia
Secondary sponsor category [1] 288434 0
None
Name [1] 288434 0
None
Address [1] 288434 0
None
Country [1] 288434 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291475 0
Alfred Health Ethics Committee
Ethics committee address [1] 291475 0
55 Commercial Road Melbourne, VICTORIA, Australia 3004
Ethics committee country [1] 291475 0
Australia
Date submitted for ethics approval [1] 291475 0
19/09/2014
Approval date [1] 291475 0
Ethics approval number [1] 291475 0

Summary
Brief summary
To date no prospective study has been undertaken to investigate the effect of haemodialysis dose delivery on the epidemiology and biological effect of blood pressure variability. This study represents the first comparative investigation between peritoneal dialysis, extended-hours
haemodialysis and conventional thrice-weekly satellite therapy, with the expectation of objectively demonstrating smoother and better control of blood pressure using home-based therapies. This study hypothesises that patients undergoing therapies with high-dose dialysis achieve better control of blood pressure with less time spent in hypertensive ranges and less blood pressure variability than patients undergoing conventional thrice-weekly satellite haemodialysis
Trial website
Trial related presentations / publications
Public notes
Non-interventional study : patients are not assigned modality of renal replacement for the purpose of this trial - their treatment pattern is prespecified through previous clinical indication.

Contacts
Principal investigator
Name 50574 0
Dr Scott Wilson
Address 50574 0
Renal Unit, L4 Main Ward Block
Alfred Hospital
55 Commercial Road MELBOURNE Victoria 3004
Country 50574 0
Australia
Phone 50574 0
613 9076 2580
Fax 50574 0
Email 50574 0
s.wilson@alfred.org.au
Contact person for public queries
Name 50575 0
Dr Scott Wilson
Address 50575 0
Renal Unit, L4 Main Ward Block
Alfred Hospital
55 Commercial Road MELBOURNE Victoria 3004
Country 50575 0
Australia
Phone 50575 0
613 9076 2580
Fax 50575 0
Email 50575 0
s.wilson@alfred.org.au
Contact person for scientific queries
Name 50576 0
Dr Scott Wilson
Address 50576 0
Renal Unit, L4 Main Ward Block
Alfred Hospital
55 Commercial Road MELBOURNE Victoria 3004
Country 50576 0
Australia
Phone 50576 0
613 9076 2580
Fax 50576 0
Email 50576 0
s.wilson@alfred.org.au

No data has been provided for results reporting
Summary results
Not applicable