Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000045516
Ethics application status
Approved
Date submitted
25/01/2006
Date registered
30/01/2006
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised comparative crossover study to assess the affect on circuit life of varying pre-dilution volumes associated with Continuous Veno-Venous Haemofiltration (CVVH) and Continuous Veno-Venous Haemodiafiltration (CVVHDF).
Scientific title
A randomised phase I study to evaluate the effects of different pre-dilution volumes associated with Continuous Veno-Venous Haemofiltration (CVVH) and Continuous Veno-Venous Haemodiafiltration (CVVHDF) to improve the efficacy of CRRT (Continuous Renal Replacement Therapy) in the treatment of severe Acute Renal Failure (ARF) by the extension of circuit life.
Secondary ID [1] 288065 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who are critically ill with Acute Renal Failure (ARF) who require Renal Replacement Therapy (RRT). 1007 0
Condition category
Condition code
Renal and Urogenital 1083 1083 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous Renal Replacement Therapy (CRRT) is an established treatment option in Australia for critically ill patients with severe Acute Renal Failure (ARF). Treatment efficiacy of CRRT is dependent on the continuous nature of the therapy to achieve azotemic control, normalisation of serum sodium, potassium and bicarbonate concentrations, and in the management of fluid volume. Due to the development of blood clots in the extracorporeal circuit the continuous nature of CRRT is interrupted. The aim of this research project is to evaluate the discontinuation of circuit life due to clotting between two widely used forms of CRRT. The impact of Continuous Veno-Venous Haemofiltration (CVVH) and Continuous Veno-Venous Haemodiafiltration (CVVHDF) will be investigated using a randomised crossover study design. Patients participating in the study will be intially randomised to receive either CVVH or CVVHDF and crossover to the other treatmenet modality only when each circuit has run its natural course. Provided the change of modality occurs sequentially and both circuits are taken down due to clotting, only one crossover between the two treatment modalities will be necessary. The patient will then resume CVVHDF in accordance with standard unit practice until CRRT is no longer required.
Intervention code [1] 867 0
None
Comparator / control treatment
N/A
Control group
Active

Outcomes
Primary outcome [1] 1448 0
Operational time of each circuit during CVVH and CVVHDF.
Timepoint [1] 1448 0
N/A
Secondary outcome [1] 2585 0
Patient survival and the return of urinary output.
Timepoint [1] 2585 0
N/A

Eligibility
Key inclusion criteria
Admission to an adult ICU and the requirement for CRRT as determined by the intensivist on duty.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A series of sealed envelopes corresponding to the patient's enrolement number will contain a specific treatment order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using a computer generated sequence of random numbers to determine which mode is to be assigned to the patient prior to commencement of treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2005
Actual
1/02/2005
Date of last participant enrolment
Anticipated
30/07/2006
Actual
31/07/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 1187 0
Government body
Name [1] 1187 0
Helen Bailey Nursing Scholarship
Country [1] 1187 0
Australia
Primary sponsor type
Government body
Name
Department of Health Western Australia
Address
N/A
Country
Australia
Secondary sponsor category [1] 1045 0
None
Name [1] 1045 0
None
Address [1] 1045 0
Country [1] 1045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2502 0
Intensive Care Unit, Royal Perth Hospital
Ethics committee address [1] 2502 0
Ethics committee country [1] 2502 0
Australia
Date submitted for ethics approval [1] 2502 0
Approval date [1] 2502 0
10/01/2005
Ethics approval number [1] 2502 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 658 658 0 0
/AnzctrAttachments/1045-CVVH&CVVHDf_CircuitLife.pdf

Contacts
Principal investigator
Name 35262 0
Dr Hugh Thomas Davies
Address 35262 0
Intensive Care Unit
Royal Perth Hospital
Wellington Street Campus
Perth 6000
Country 35262 0
Australia
Phone 35262 0
08 92244 1060
Fax 35262 0
Email 35262 0
hugh.davies@health.wa.gov.au
Contact person for public queries
Name 10056 0
Mr Hugh Davies
Address 10056 0
Intensive Care Unit
Royal Perth Hospital
Wellington Street Campus
Perth 6000 WA
Country 10056 0
Australia
Phone 10056 0
+61 8 92242244 ext. 42727
Fax 10056 0
+61 8 92243196
Email 10056 0
hugh.davies@health.wa.gov.au
Contact person for scientific queries
Name 984 0
Mr Hugh Davies
Address 984 0
40 Coatbridge Circuit
Kinross Perth WA 6028
Country 984 0
Australia
Phone 984 0
+61 8 93047174
Fax 984 0
Email 984 0
hugh.davies@ozemail.com.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.