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

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ClinicalTrials.gov Identifier: NCT00221013
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 27, 2009
Sponsor:
Collaborator:
ANZICS Clinical Trials Group
Information provided by:
The George Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Renal Failure Procedure: "augmented" CRRT regimen Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : November 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Death from all causes at 90 days after randomisation. [ Time Frame: Within 90 days after randomisation ]

Secondary Outcome Measures :
  1. Death within the in the intensive care unit. [ Time Frame: 0 to 90 days ]
  2. Death within 28 days of randomisation. [ Time Frame: Within 28 days of randomisation. ]
  3. Death prior to hospital discharge. [ Time Frame: 0 to 90 days ]
  4. Length of ICU stay. [ Time Frame: 0 to 90 days ]
  5. Length of hospital stay. [ Time Frame: 0 to 90 days ]
  6. The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation). [ Time Frame: 0 to 90 days ]
  7. CRRT-free days. [ Time Frame: 0 to 90 days ]
  8. Dialysis-independent survival. [ Time Frame: 0 to 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

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:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases