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

NCT00830193 | Completed Phase 2

• 1 other identifier: LHRI-000001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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 dysfunction. The investigators investigated the effects of high dose N-acetylcysteine (NAC) or placebo, in addition to hydration, in preventing kidney dysfunction following contrast enhanced CT) in critically ill adults in the intensive care units of two teaching hospitals.

Conditions

Contrast Induced Nephropathy; Critically Ill

Keywords

N-acetylcysteine; prevention; contrast-induced nephropathy; critically ill adults

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (5)

• ICU length of stay

  ICU stay

• Hospital length of stay

  Hospital stay

• ICU mortality

  ICU stay

• Hospital Mortality

  Hospital stay

• Requirement for Renal Replacement Therapy

  ICU

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT. Patients randomized to the experimental arm received intravenous normal saline plus NAC 10 grams IV (5 g pre and 2.5 g at 6 and 12 hours post-exposure) for a total of 3 doses.

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT. Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g in 100 cc D5W (pre-CT dose) or 2.5 g in 50 cc D5W (post-CT doses). The placebo was D5W and was colour and consistency matched by pharmacy. Patients randomized to placebo received intravenous normal saline plus 3 doses of placebo.

Drug: D5W Placebo

Interventions

N-acetylcysteine DRUG

Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo in 100 cc D5W (pre-CT dose) or 2.5 g of NAC or placebo in 50 cc D5W (post-CT doses).

Also known as: Mucomyst

N-acetylcysteine

D5W Placebo DRUG

Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo (D5W) in 100 cc D5W (pre-CT dose) or 2.5 g NAC or placebo in 50 cc D5W (post-CT doses).

Also known as: D5W

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Martin, Claudio M., M.D.: collaborator
• Fran Priestap: collaborator

Study Sites (2)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

London Health Sciences Centre - University Hospital Campus

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Claudio M Martin, MD, FRCPC, MSc

  London Health Sciences Centre - Victoria Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 27, 2009
• Study Start: August 1, 2002
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: January 27, 2009

Record last verified: 2009-01

Locations

CA (2)