Status:

COMPLETED

The Optimal Mode of Renal Replacement Therapy in Acute Kidney Injury (OMAKI) Study

Lead Sponsor:

Unity Health Toronto

Collaborating Sponsors:

University of Toronto

Conditions:

Acute Kidney Injury

Eligibility:

All Genders

16+ years

Phase:

PHASE4

Brief Summary

Acute kidney injury (AKI) in the intensive care unit is common, devastating and costly. However, minimal evidence exists to guide the prescription of optimal renal replacement therapy (RRT). An import...

Detailed Description

The optimal mode of clearance in critically ill patients with acute kidney injury (AKI) who require renal replacement therapy (RRT) is unclear. Although both convection (as provided by hemofiltration)...

Eligibility Criteria

Inclusion

  • Adult patients (over 16 years of age) admitted to a participating ICU
  • Serum creatinine increase of ≥ 50% from baseline
  • Hemodynamic instability as defined by the cardiovascular component of the SOFA score of ≥ 1
  • Attending physician deems the patient a candidate for RRT for at least one of the following reasons:
  • Presence of oliguria, defined as a urine output of \< 100 mL in the preceding 4 hours
  • metabolic acidosis (HCO3- \< 15 mmol/L and pH \< 7.25)
  • refractory hyperkalemia (K \> 6.0 mmol/L)
  • azotemia (BUN \> 50 mmol/L)
  • suspected uremic organ involvement (pericarditis, encephalopathy, neuropathy or myopathy)

Exclusion

  • renal replacement therapy within the previous 2 months
  • presence of renal obstruction
  • receipt of a kidney transplant in the previous year
  • diagnosis of rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
  • indication for intermittent hemodialysis, specifically severe hyperkalemia, dialyzable drug or toxin
  • terminal illness with associated life expectancy less than 2 months
  • patients who are moribund
  • prior enrollment in this study
  • enrollment in a competing ICU interventional study
  • no CRRT machine available
  • acute renal replacement ongoing for \> 36 hours

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT00675818

Start Date

May 1 2008

End Date

October 1 2010

Last Update

March 12 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

University of Alberta

Edmonton, Alberta, Canada

2

London Health Sciences Centre

London, Ontario, Canada

3

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

4

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8