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Technical measurement problems led to unreliable or uninterpretable data.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine | Active Comparator | Oral N-Acetylcysteine 600 mg |
|
| Sodium Bicarbonate | Active Comparator | Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral N-Acetylcysteine | Drug | 600 milligrams (mg) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria: 19 years of age
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
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| Name | Affiliation | Role |
|---|---|---|
| Scott Shurmur, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1, N-Acetylcysteine | Oral N-Acetylcysteine - 600 milligram (mg) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1, N-Acetylcysteine | Oral N-acetylcysteine - 600 mg |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | milligrams per deciliter | 2 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1, N-Acetylcysteine | Oral N-acetylcysteine 600 mg |
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Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data. Rate of 72 hour Creatinine determination was poor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Shurmur, M.D. | University of Nebraska Medical Center | 402-559-6463 | sshurmur@unmc.edu |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Sodium Bicarbonate | Drug | 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 |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 2, Sodium Bicarbonate | 3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure | 0 | 23 | 0 | 23 |
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| D052801 | Male Urogenital Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |