Trial Outcomes & Findings for A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate (NCT NCT00579995)
NCT ID: NCT00579995
Last Updated: 2023-09-21
Results Overview
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
2 years
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
1, N-Acetylcysteine
Oral N-Acetylcysteine - 600 milligram (mg)
|
2, Sodium Bicarbonate
Sodium bicarbonate, 3 milliliters per kilogram per hour (3 mL/kg/hr) for one hour pre-procedure and infused at 1 mL/kg/hr for 6 hrs post-procedure
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
23
|
|
Overall Study
COMPLETED
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
Baseline characteristics by cohort
| Measure |
1, N-Acetylcysteine
n=18 Participants
Oral N-acetylcysteine - 600 mg
|
2, Sodium Bicarbonate
n=23 Participants
Sodium bicarbonate 3 mL/kg/hr for one hour pre-procedure and infused at 1 mL/kg/hr for 6 hours post-procedure.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
60 years
STANDARD_DEVIATION 4.4 • n=107 Participants
|
61 years
STANDARD_DEVIATION 4.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
23 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsCompare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
Outcome measures
| Measure |
1, N-Acetylcysteine
n=18 Participants
N-Acetylcysteine - 600 milligram (mg)
|
2, Sodium Bicarbonate
n=23 Participants
3 milliliter per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post procedure
|
|---|---|---|
|
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
|
NA milligrams per deciliter
Standard Deviation NA
Technical problems with measurement leading to unreliable or uninterpretable data.
|
NA milligrams per deciliter
Standard Deviation NA
Technical problems with measurement leading to unreliable or uninterpretable data.
|
Adverse Events
1, N-Acetylcysteine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2, Sodium Bicarbonate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Scott Shurmur, M.D.
University of Nebraska Medical Center
Phone: 402-559-6463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place