Status:
COMPLETED
Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF).
Lead Sponsor:
The George Institute
Collaborating Sponsors:
ANZICS Clinical Trials Group
Conditions:
Acute Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 fai...
Detailed Description
Study Title - Multicentre, Unblinded, Randomised, Controlled Trial to assess the effect of Augmented vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-day all-cause mortality of Intensive C...
Eligibility Criteria
Inclusion
- The treating clinician believes that the patient requires CRRT for acute renal failure.
- The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT.
- The treating clinicians anticipate treating the patient with CRRT for at least 72 hours.
- Informed consent has been obtained
- 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).
Exclusion
- Patient age is \<18 years.
- Death is imminent (\<24 hours).
- There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol.
- The patient has been treated with CRRT or other dialysis previously during the same hospital admission.
- The patient was on maintenance dialysis prior to the current hospitalisation.
- The patient's body weight is \<60 kg or \>100kg.
- Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1508 Patients enrolled
Trial Details
Trial ID
NCT00221013
Start Date
November 1 2005
End Date
January 1 2009
Last Update
February 27 2009
Active Locations (1)
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1
The Austin Hopsital
Heidelberg, Victoria, Australia, 3084