| Trial ID: | L0295 |
| Source ID: | NCT01210456
|
| Associated Drug: |
Physiological Saline, N-Acetylcysteine And Sodium Bicarbonate
|
| Title: |
Efficacy Trial of N-Acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-Induced Acute Kidney Injury
|
| Acronym: |
PREKIT
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate
|
| Outcome Measures: |
Primary: Development of contrast-induced acute kidney injury, Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of intravascular contrast administration in the absence of any alternative causes, or a reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than six hours., within 48 hours | Secondary: Requirement of dialysis, 6 months|Requirement of hospitalization and death, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Tokushukai Medical Group
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
458
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2009-10
|
| Completion Date: |
2014-11
|
| Results First Posted: |
|
| Last Update Posted: |
2014-09-16
|
| Locations: |
Sapporo Higashi Tokushukai Hospital, Sapporo City, Hokkaido, 065-0033, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01210456
|
