Not Yet RecruitingPhase 4ACTRN12605000059662

Multicentre, Unblinded, Randomised, Controlled Trial of Severe Acute Renal Failure (ARF)

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)

Sponsor

The George Institute

Enrollment

1,500 participants

Start Date

Nov 1, 2005

Study Type

Interventional

Conditions

Acute Renal Failure

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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.

Exclusion Criteria1

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.

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