A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate (PROTECt)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00579995
First received: December 18, 2007
Last updated: June 25, 2010
Last verified: June 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 18, 2007 | ||||
| Last Updated Date | June 25, 2010 | ||||
| Start Date ICMJE | May 2005 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
to compare the effectiveness of two medications, oral N-acetylcysteine (mucomyst) and intravenous sodium bicarbonate, used to protect the kidneys from contrast injury during a cardiac catheterization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00579995 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate | ||||
| Official Title ICMJE | A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization | ||||
| Brief Summary | The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Preserving Kidney Function in People Who Are at High Risk of Developing Contrast-induced Nephropathy | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | January 2011 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 19 years of age
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00579995 | ||||
| Other Study ID Numbers ICMJE | 120-05-FB | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Scott Shurmur, M.D., University of Nebraska Medical Center | ||||
| Study Sponsor ICMJE | University of Nebraska | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Nebraska | ||||
| Verification Date | June 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||