Status:
COMPLETED
N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Martin, Claudio M., M.D.
Fran Priestap
Conditions:
Contrast Induced Nephropathy
Critically Ill
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
Critically ill patients frequently undergo contrast enhanced computed tomography (CT) to establish diagnoses and direct management. Contrast agents can disturb kidney function and result in kidney dys...
Detailed Description
Potential participants were identified by staff intensivists or resident physicians following admission to participating ICUs. We included critically ill adult patients at least 18 years of age who co...
Eligibility Criteria
Inclusion
- The investigators included critically ill adult patients at least 18 years of age who consented to participate in the trial, had central venous access and a foley catheter, required a contrast-enhanced CT of any organ system(s), and were considered 'at risk' for the development of CIN.
- The investigators defined 'at risk' to include patients with at least one of the following at the time of randomization (i) a serum creatinine of \> 106 µmol/L and or urea \> 6 mmol/L, (ii) urine output of \< 0.5 cc/kg over \> 4 hrs or (iii) an increase in serum creatinine of \> 50 µmol/L in \< 24 hours.
Exclusion
- The investigators excluded patients with a
- CK \> 5,000 or the presence of myoglobinuria
- a known allergy or hypersensitivity reaction to radiographic contrast dye or NAC
- serious illness with imminent threat of dying (low likelihood of survival within 48-hours) or poor prognosis
- pregnancy
- patients with cardiogenic shock (NYHA class 3 or 4 symptoms)
- known or suspected nephritic, nephrotic or pulmonary-renal syndromes
- a post renal etiology of renal impairment
- previous renal transplant
- known solitary kidney
- serum creatinine \> 200 µmol/L or (xi) recent exposure to radiographic contrast within 14 days of randomization.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00830193
Start Date
August 1 2002
End Date
May 1 2005
Last Update
January 27 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 4G5
2
London Health Sciences Centre - University Hospital Campus
London, Ontario, Canada, N6A 5A5