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| Name | Class |
|---|---|
| Medley Pharmaceutical Industry SA | UNKNOWN |
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The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylcysteine | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylcysteine | Drug | Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography. |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-induced nephropathy incidence | between 48 and 96 hours after angiographic procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication | within 30 days | |
| Combined outcome of total mortality or dialysis indication | within 30 days | |
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Inclusion Criteria:
At least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Sousa, PhD | Hospital do Coracao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Coração | São Paulo | São Paulo | 04004030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23572490 | Derived | Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9. | |
| 21859972 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography. |
|
| The individual components of the combined outcome |
| within 30 dias |
| Derived |
| ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22. |
| 19497091 | Derived | ACT Trial Investigators. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |