Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000059662
Ethics application status
Approved
Date submitted
22/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Multicentre, Unblinded, Randomised, Controlled Trial of Severe Acute Renal Failure (ARF)
Scientific title
Multicentre, Unblinded, Randomised, Controlled Trial to assess the effect of augmented v normal continuous renal replacement therapy (CRRT) on 90-day all cause mortality of intensive care unit patients with severe acute renal failure (ARF)
Universal Trial Number (UTN)
Trial acronym
RENAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 131 0
Condition category
Condition code
Renal and Urogenital 150 150 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute Renal Failure Management with an Augmented vs. Normal Continuous Renal Replacement Therapy (CRRT) Regimen in Intensive Care Unit Patients.
Intervention code [1] 49 0
None
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 186 0
The primary study outcome is death from all causes at 90 days after randomisation.
Timepoint [1] 186 0
Every randomised patient will be followed up until either death or 90 days post-randomisation as recommended by the UK Medical Research Council International Working Party for Clinical Trials in Patients with Sepsis and Septic Shock.
Secondary outcome [1] 416 0
Death in the intensive care unit.
Timepoint [1] 416 0
Secondary outcome [2] 417 0
Death within 28 days of randomisation.
Timepoint [2] 417 0
Secondary outcome [3] 418 0
Death prior to hospital discharge.
Timepoint [3] 418 0
Secondary outcome [4] 419 0
Length of ICU stay.
Timepoint [4] 419 0
Secondary outcome [5] 420 0
Length of hospital stay.
Timepoint [5] 420 0
Secondary outcome [6] 421 0
The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
Timepoint [6] 421 0
Secondary outcome [7] 422 0
CRRT-free days.
Timepoint [7] 422 0
Secondary outcome [8] 423 0
Dialysis-independent survival.
Timepoint [8] 423 0

Eligibility
Key inclusion criteria
1.The treating clinician believes that the patient requires CRRT for acute renal failure. 2. The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT. 3. The patient fulfils one of the following clinical criteria for initiating CRRT: Oliguria (urine output < 100ml/6hr) that has been unresponsive to fluid resuscitation measures. Hyperkalemia ([K+] > 6.5 mmol/liter). Severe acidemia (pH < 7.2). Urea > 25mmol/liter. Clinically significant organ oedema (eg: lung). Creatinine >300mmol/liter 4. The treating clinicians anticipate treating the patient with CRRT for at least 72 hours.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient age is <18 years. 2. Death is imminent (<24 hours). 3. There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol. 4. The patient has been treated with CRRT or other dialysis previously during the same hospital admission. 5. The patient was on maintenance dialysis prior to the current hospitalization. 6. The patients body weight is <60kg or >100kg. 7. Any other major illness that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in this study.

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)
Central randomisation via telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated using minimisation - stratified according to study centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 202 0
Government body
Name [1] 202 0
NHMRC
Country [1] 202 0
Australia
Primary sponsor type
Other
Name
The George Institute
Address
Country
Australia
Secondary sponsor category [1] 151 0
None
Name [1] 151 0
None
Address [1] 151 0
Country [1] 151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 965 0
Austin Hospital,
Ethics committee address [1] 965 0
Heidelberg, VIC 3084
Ethics committee country [1] 965 0
Australia
Date submitted for ethics approval [1] 965 0
Approval date [1] 965 0
Ethics approval number [1] 965 0

Summary
Brief summary
Patients who have developed kidney failure in the intensive care unit (ICU) ar being invited to take part in a clinical research study comparing two different types of artifical kidney treatment, which doctors call continuous renal replacement therapy or CRRT for short. The goal of the study is to compare two doses of CRRT. This treatment is also commonly known as continuous dialysis. As it stands doctors are uncertain as to the best level of intensity of treatment with a kidney machine in this setting and wish to do a study comparing two levels of treatment to see which one is best for patients with this condition.
If a patient has acute renal failure and they require treatmnet they will still receive one of these treatments because their kidneys are failing.
The CRRT two doses are:
1. Continuous renal replacement therapy at 40 ml/kg/hr (about 3 litres per hour) of fluid exchange
or
2. Continuous renal replacement therapy at 25 ml/kg/hr (about 2 litres per hour) of fluid exchange.
This study will involve 1500 patients from 30 Intensive Care Units in Australia and New Zealand and will include all types of patients admitted to Intensive Care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36286 0
Address 36286 0
Country 36286 0
Phone 36286 0
Fax 36286 0
Email 36286 0
Contact person for public queries
Name 9238 0
Dr David Ali - Senior Project Manager - RENAL STUDY
Address 9238 0
The George Institute for International Health
King George V Building
Level 10
Royal Prince Alfred Hospital
Missenden Road
Camperdown Sydney NSW 2050
Country 9238 0
Australia
Phone 9238 0
+61 2 99934500
Fax 9238 0
+61 2 99934502
Email 9238 0
[email protected]
Contact person for scientific queries
Name 166 0
Prof Rinaldo Bellomo,
Address 166 0
Intensive Care Unit
Austin Hospital
Studley Rd
Heidelberg VIC 3084
Country 166 0
Australia
Phone 166 0
+61 3 94965992
Fax 166 0
+61 3 94965992
Email 166 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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