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

This study has been completed.
Sponsor:
Collaborator:
ANZICS Clinical Trials Group
Information provided by:
The George Institute
ClinicalTrials.gov Identifier:
NCT00221013
First received: September 14, 2005
Last updated: February 25, 2009
Last verified: February 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Acute Renal Failure
 Procedure: "augmented" CRRT regimen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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).

Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Death from all causes at 90 days after randomisation. [ Time Frame: Within 90 days after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death within the in the intensive care unit. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • Death within 28 days of randomisation. [ Time Frame: Within 28 days of randomisation. ] [ Designated as safety issue: No ]
  • Death prior to hospital discharge. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • Length of ICU stay. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • Length of hospital stay. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation). [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • CRRT-free days. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]
  • Dialysis-independent survival. [ Time Frame: 0 to 90 days ] [ Designated as safety issue: No ]

Enrollment: 1508
Study Start Date: November 2005
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Higher intensity CRRT regimen Procedure: "augmented" CRRT regimen
We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.
Active Comparator: Lower intensity CRRT regimen Procedure: "augmented" CRRT regimen
We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221013

Locations
Australia, Victoria
The Austin Hopsital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
The George Institute
ANZICS Clinical Trials Group
Investigators
Study Chair: Prof Rinaldo Bellomo, MD Austin Hospital, Melbourne Australia
Principal Investigator: Alan Cass, MD The George Institute
Principal Investigator: Simon Finfer, MD Royal North Shore Hospital
Principal Investigator: Carlos Scheinkestel, MD The Alfred
Principal Investigator: Robyn Norton, MD The George Institute
Principal Investigator: John Myburgh, MD St George Hospital (Sydney)
Principal Investigator: Louise Cole, MD Nepean Blue Mountains Local Health District
Principal Investigator: Martin Gallagher, MD The George Institute
Principal Investigator: Shay McGuinness, MD Auckland City Hospital CVICU
Principal Investigator: Colin McArthur, MD Auckland City Hospital DCCM
  More Information

Additional Information:
Renal Study Website.  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Project Manager, The George Institute
ClinicalTrials.gov Identifier: NCT00221013     History of Changes
Other Study ID Numbers: GI-RE-ARF001-40-R, 352550
Study First Received: September 14, 2005
Last Updated: February 25, 2009
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The George Institute:
Acute Renal Failure
Continuous Renal Replacement Therapy
Continuous Veno-Venous Haemofiltration
Continuous Veno-Venous Haemodiafiltration
Renal Replacement Therapy

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013