Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00780962 | N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients | PHASE2 | COMPLETED | 399 | — | — | Oct 16, 2007 | Aug 9, 2010 | Oct 29, 2024 | 1 | United States |
Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.
| Arm | Type | Description |
|---|---|---|
| N-Acetylcysteine group | EXPERIMENTAL | Subjects in this group will receive 3 grams of N-acetylcysteine in 500 cc normal saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, they will receive a continuous infusion of 200 mg N-acetylcysteine per hour. This dose will be administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine in 1000 cc of normal saline. The infusion will be administered for a minimum of two hours and then stopped after 24 hours, or when the patient is discharged from the Emergency Department or the hospital, whichever comes first. |
| 0.9% Sodium-chloride group | PLACEBO_COMPARATOR | Subjects in this group will receive 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, they will receive a continuous infusion of 67 cc per hour of normal saline. The infusion will be administered for a minimum of two hours and then stopped after 24 hours, or when the patient is discharged from the Emergency Department or the hospital, whichever comes first. |
| Name | Type | Description |
|---|---|---|
| N-Acetylcysteine (NAC) | DRUG | Experimental: * Before CT: 3 g NAC IV in 500 cc of 0.9% Sodium-chloride * After CT: 200 mg NAC/hour in 0.9% Sodium-chloride at 67 cc/hour for up to 24 hours. |
| 0.9% Sodium-chloride | DRUG | Placebo: * Before CT: 500 cc 0.9% Sodium-chloride * After CT: NS at 67 cc/hour for up to 24 hours. |
Inclusion Criteria: * Undergoing a CT with intravenous contrast as part of clinical care * 18 years of age or older * Willingness to have a serum creatinine measured 48-72 hours after study * Presence of one or more risk factors for radiocontrast nephropathy: * Creatinine greater than or equal t...