RCT of Normal vs. Augmented Level of Renal Replacement Therapy in ICU - RENAL
Background
Some evidence suggests that using higher-than-normal (or "augmented") doses of renal replacement therapy improves the survival of patients with kidney failure in intensive care units (ICUs). The improvements in survival seen in a previous single-centre Italian study were enough to suggest that wider adoption of higher doses could save a considerable number of lives. The previous study treated a different patient mix to that typically seen in an Australian ICU and required validation in large multicentre RCTs.
Aims
The RENAL study (Randomised Evaluation of Normal vs Augmented Level of renal replacement therapy in ICU) studied the effect of different doses of dialysis (renal replacement therapy) in patients with severe, acute kidney failure in the intensive care unit (ICU).
Methods
The study involved 35 ICUs from around Australia and New Zealand, and enrolled1500 patients over a two-year period. Patients presenting to those ICUs requiring renal replacement therapy were randomly allocated to receive either an augmented dose or normal dose of renal replacement therapy as part of their usual treatment in ICU. The study measured the survival of patients at 28 and 90 days following admission to the ICU.
Status/Results
As of Mar 2009:
The RENAL study is complete with four publications released to date:
- Renal replacement therapy for acute kidney injury in Australian and New Zealand intensive care units: a practice survey. Crit Care Resusc 2008; 10: 225-230.
- Design and Challenges of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Trial: High-Dose versus Standard-Dose Hemofiltration in Acute Renal Failure. Blood Purif 2008;26:407-416
- Screening and Study Enrolment in the Randomized Evaluation of Normal vs Augmented Level (RENAL) Replacement Therapy Trial. Blood Purif 2009;27:199-205
- The Randomized Evaluation of Normal vs. Augmented Level Replacement Therapy (RENAL) Trial: A statistical analysis plan. Crit care Resusc 2009; 11: 58-66
The core manuscript titled "Intensity of Continuous Renal Replacement Therapy in Critically Ill Patients" (09-02413) was submitted for consideration for publication on 18 March 2009.
The RENAL Study is now the largest ever Continuous Renal Replacement Therapies (CRRT) trial completed.
Final Study Status:
- Database lock date met as per schedule on 14 January 2009
- Number of sites: 35 (ANZ)
- Total number of patients enrolled: 1508 (Target: 1500)
- Consent withdrawn: 43 (2%)
- Reportable serious adverse events: 13 (1%)
Institute Investigators
- Professor Alan Cass
- Dr Martin Gallagher
- Professor John Myburgh
- Professor Simon Finfer
- Professor Robyn Norton
Project Manager
- Ms Joanne Lee
Clinical Research Associates
- Lorraine Little
- Joanne Regaglia
- Ravi Shukla
