Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF)

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).

Official 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).

Conditions

Acute Renal Failure

Study Type

Interventional

Study Design

Educational/Counseling/Training, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Death from all causes at 90 days after randomisation.

Secondary Outcome Measures:

• Death within the 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.

Study Start

November 2005; Expected completion: May 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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 x 10^-6 mol/L in the setting of ARF.
   • Clinically significant organ oedema in the setting of ARF (eg: lung).

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.

Total Enrolment

1500

Contact Details

34 Centres distributed in both Australia and New Zealand will participate in the study.

• David Ali, PhD; +61 2 99934567 Ext. 567, dali@thegeorgeinstitute.org
• Martin Gallagher, MD; +61 2 9993 4552 Ext. 552, mgallagher@thegeorgeinstitute.org

Austin Hospital, Melbourne, Victoria, 3000, Australia; Recruiting

• Rinaldo Bellomo, MD +61 3 9496 5992 rinaldo.bellomo@austin.org.au
• Donna Goldsmith +61 3 9496 4835 donna.goldsmith@austin.org.au