| Trial ID: | L1420 |
| Source ID: | NCT01359722
|
| Associated Drug: |
N-Acetylcysteine
|
| Title: |
N-acetylcysteine to Prevent Renal Failure
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Acute|Oxidative Stress Induction
|
| Interventions: |
DRUG: N-acetylcysteine|DRUG: Control
|
| Outcome Measures: |
Primary: Decrease in glomerular filtration defined by at least 30% compared to preoperative levels ., Within the first 72 hours postoperatively | Secondary: Up 50% of preoperative levels of serum creatinine., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Death from any cause., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Need for dialysis, Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Cardiovascular morbidity., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Increased levels of Cystatin C., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Increased levels of NGAL., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.|Increased levels of isoprostane., Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively.
|
| Sponsor/Collaborators: |
Sponsor: Instituto do Coracao | Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2010-03
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2011-05-25
|
| Locations: |
Instituto do Coracao, Sao Paulo, 05403-900, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT01359722
|
