Multicentre, Unblinded, Randomised, Controlled Trial of Severe Acute Renal Failure (ARF)
- Conditions
- Acute Renal FailureRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12605000059662
- Lead Sponsor
- The George Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1500
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study outcome is death from all causes at 90 days after randomisation.[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 Measures
Name Time Method Death in the intensive care unit.[];Death within 28 days of randomisation.[];Death prior to hospital discharge.[];Length of ICU stay.[];Length of hospital stay. [];The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).[];CRRT-free days.[];Dialysis-independent survival.[]