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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00221013
Registration number
NCT00221013
Ethics application status
Date submitted
14/09/2005
Date registered
22/09/2005
Date last updated
27/02/2009
Titles & IDs
Public title
Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF).
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Scientific title
Multicentre, Unblinded, Open Label, Randomised, Controlled Trial to Assess the Effect of Augmented Vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-Day All-Cause Mortality of Intensive Care Unit Patients With Severe Acute Renal Failure (ARF).
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Secondary ID [1]
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352550
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Secondary ID [2]
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GI-RE-ARF001-40-R
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Injuries and Accidents
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - "augmented" CRRT regimen
Experimental: Higher intensity CRRT regimen -
Active Comparator: Lower intensity CRRT regimen -
Treatment: Surgery: "augmented" CRRT regimen
We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death from all causes at 90 days after randomisation.
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Assessment method [1]
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Timepoint [1]
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Within 90 days after randomisation
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Secondary outcome [1]
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Death within the in the intensive care unit.
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Assessment method [1]
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Timepoint [1]
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0 to 90 days
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Secondary outcome [2]
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Death within 28 days of randomisation.
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Assessment method [2]
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Timepoint [2]
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Within 28 days of randomisation.
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Secondary outcome [3]
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Death prior to hospital discharge.
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Assessment method [3]
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Timepoint [3]
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0 to 90 days
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Secondary outcome [4]
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Length of ICU stay.
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Assessment method [4]
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Timepoint [4]
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0 to 90 days
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Secondary outcome [5]
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Length of hospital stay.
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Assessment method [5]
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Timepoint [5]
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0 to 90 days
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Secondary outcome [6]
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The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
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Assessment method [6]
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0
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Timepoint [6]
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0 to 90 days
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Secondary outcome [7]
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CRRT-free days.
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Assessment method [7]
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Timepoint [7]
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0 to 90 days
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Secondary outcome [8]
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Dialysis-independent survival.
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Assessment method [8]
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Timepoint [8]
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0 to 90 days
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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 treating clinicians anticipate treating the patient with CRRT for at least 72
hours.
4. Informed consent has been obtained
5. 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/L).
- Severe acidemia (pH < 7.2).
- Urea > 25 mmol/liter.
- Creatinine >300 micromol/L in the setting of ARF.
- Clinically significant organ oedema in the setting of ARF (eg: lung).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 hospitalisation.
6. The patient's body weight is <60 kg or >100kg.
7. Any other major illness that, in the investigator's judgment, will substantially
increase the risk associated with the subject's participation in this study.
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2009
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Sample size
Target
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Accrual to date
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Final
1508
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Austin Hopsital - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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ANZICS Clinical Trials Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study seeks to determine if increasing the dose of continuous renal replacement therapy
(CRRT) reduces 90-day all cause mortality in Intensive Care Unit (ICU) patients with severe
acute renal failure (ARF).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00221013
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Trial related presentations / publications
RENAL Study Investigators. Renal replacement therapy for acute kidney injury in Australian and New Zealand intensive care units: a practice survey. Crit Care Resusc. 2008 Sep;10(3):225-30.
RENAL Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Goldsmith D, Myburgh J, Norton R, Scheinkestel C. Design and challenges of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Trial: high-dose versus standard-dose hemofiltration in acute renal failure. Blood Purif. 2008;26(5):407-16. doi: 10.1159/000148400.
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Public notes
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Contacts
Principal investigator
Name
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Prof Rinaldo Bellomo, MD
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Address
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Austin Hospital, Melbourne Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00221013
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