Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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).
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).
Secondary ID [1] 0 0
352550
Secondary ID [2] 0 0
GI-RE-ARF001-40-R
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death from all causes at 90 days after randomisation.
Timepoint [1] 0 0
Within 90 days after randomisation
Secondary outcome [1] 0 0
Death within the in the intensive care unit.
Timepoint [1] 0 0
0 to 90 days
Secondary outcome [2] 0 0
Death within 28 days of randomisation.
Timepoint [2] 0 0
Within 28 days of randomisation.
Secondary outcome [3] 0 0
Death prior to hospital discharge.
Timepoint [3] 0 0
0 to 90 days
Secondary outcome [4] 0 0
Length of ICU stay.
Timepoint [4] 0 0
0 to 90 days
Secondary outcome [5] 0 0
Length of hospital stay.
Timepoint [5] 0 0
0 to 90 days
Secondary outcome [6] 0 0
The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
Timepoint [6] 0 0
0 to 90 days
Secondary outcome [7] 0 0
CRRT-free days.
Timepoint [7] 0 0
0 to 90 days
Secondary outcome [8] 0 0
Dialysis-independent survival.
Timepoint [8] 0 0
0 to 90 days

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).
Minimum age
18 Years
Maximum age
No limit
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 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
1508
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Austin Hopsital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ANZICS Clinical Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Rinaldo Bellomo, MD
Address 0 0
Austin Hospital, Melbourne Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00221013