Nephropathy
Conditions
Keywords
contrast induced nephropathy
Brief summary
The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.
Detailed description
It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.
Interventions
600 milligrams (mg)
DRUGSodium Bicarbonate
3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
19 years of age * Baseline serum creatinine or * Calculated creatinine * Stable Renal Function * Left Ventricular ejection fraction * Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required * Able to sign informed consent
Exclusion criteria
* Acute renal failure * History of Kidney transplant * Currently receiving N-acetylcysteine \_ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate * Left ventricular ejection fraction * Pregnant, lactating females * Allergy to contrast dye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy | 2 years | Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1, N-Acetylcysteine Oral N-acetylcysteine - 600 mg | 18 |
| 2, Sodium Bicarbonate Sodium bicarbonate 3 mL/kg/hr for one hour pre-procedure and infused at 1 mL/kg/hr for 6 hours post-procedure. | 23 |
| Total | 41 |
Baseline characteristics
| Characteristic | 2, Sodium Bicarbonate | 1, N-Acetylcysteine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 10 Participants | 25 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 4.4 | 62 years STANDARD_DEVIATION 3.8 | 61 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment United States | 23 participants | 18 participants | 41 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 18 Participants | 12 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 23 |
| serious Total, serious adverse events | 0 / 18 | 0 / 23 |
Outcome results
Primary
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1, N-Acetylcysteine | Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy | NA milligrams per deciliter |
| 2, Sodium Bicarbonate | Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy | NA milligrams per deciliter |