N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00830193
• Date of registration: 13/01/2009
• Prospective Registration: No
• Primary sponsor: St. Michael's Hospital, Toronto
• Public title: N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography
• Scientific title: N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography: A Randomized Trial
• Date of first enrolment: August 2002
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00830193
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Claudio M Martin, MD, FRCPC, MSc
• Affiliation: London Health Sciences Centre - Victoria Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critically Ill

Contrast Induced Nephropathy

Intervention(s)

Drug: D5W Placebo

Drug: N-acetylcysteine

Primary Outcome(s)

The primary outcome for the study was the development of CIN defined as a rise in serum creatinine of > 50 µmol/L from the time of randomization up to day 5 following contrast exposure. [Time Frame: 5 days]

Secondary Outcome(s)

ICU mortality [Time Frame: ICU stay]

Requirement for Renal Replacement Therapy [Time Frame: ICU]

Hospital Mortality [Time Frame: Hospital stay]

ICU length of stay [Time Frame: ICU stay]

Hospital length of stay [Time Frame: Hospital stay]

Secondary ID(s)

LHRI-000001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Martin, Claudio M., M.D.

Fran Priestap