Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF).
Launched by THE GEORGE INSTITUTE · Sep 14, 2005
Trial Information
Current as of April 26, 2025
Completed
Keywords
ClinConnect Summary
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 Care Unit Patients with Severe Acute Renal Failure (ARF).
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting. This evidence will have direct relevance to decisions about the care...
Gender
ALL
Eligibility criteria
- 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 micromol/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.
About The George Institute
The George Institute for Global Health is a leading research organization dedicated to improving health outcomes through innovative clinical trials and groundbreaking research. Based in Australia, the institute focuses on addressing major health challenges, particularly in the areas of chronic diseases, cardiovascular health, and health equity. With a commitment to translating scientific discoveries into real-world applications, The George Institute collaborates with global partners to advance knowledge and implement effective health interventions. Its multidisciplinary team of researchers employs rigorous methodologies to ensure high-quality evidence that informs policy and practice, ultimately striving to enhance public health on a global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, Victoria, Australia
Patients applied
Trial Officials
Prof Rinaldo Bellomo, MD
Study Chair
Austin Hospital, Melbourne Australia
Alan Cass, MD
Principal Investigator
The George Institute
Simon Finfer, MD
Principal Investigator
Royal North Shore Hospital
Carlos Scheinkestel, MD
Principal Investigator
The Alfred
Robyn Norton, MD
Principal Investigator
The George Institute
John Myburgh, MD
Principal Investigator
St George Hospital (Sydney)
Louise Cole, MD
Principal Investigator
Nepean Blue Mountains Local Health District
Martin Gallagher, MD
Principal Investigator
The George Institute
Shay McGuinness, MD
Principal Investigator
Auckland City Hospital CVICU
Colin McArthur, MD
Principal Investigator
Auckland City Hospital DCCM
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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