| Trial ID: | L1418 |
| Source ID: | NCT02467075
|
| Associated Drug: |
Iopamidol 300 (Contrast)
|
| Title: |
Double-Blind Placebo-Controlled CIN Trial
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02467075/results
|
| Conditions: |
Acute Kidney Injury
|
| Interventions: |
DRUG: Iopamidol 300 (Contrast)|DRUG: Placebo (Normal Saline)
|
| Outcome Measures: |
Primary: Participants With Stage II AKI (Acute Kidney Injury), Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working., 48 hours | Secondary: Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition, Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity, 48-72 hours|Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis), Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation., 30 days|Hospital Length of Stay, Subject's hospital length of stay in days, Duration of hospital stay (assessed from date of randomization up to 30 days)|30-day Readmission, Number of times a subject is readmitted within 30 days of study recruitment, 30 days|Mortality Rate - 30 Day, Number of subjects who died within 30 days of entry into the study., 30 days
|
| Sponsor/Collaborators: |
Sponsor: University of Michigan | Collaborators: Radiological Society of North America
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2015-07
|
| Completion Date: |
2015-09
|
| Results First Posted: |
2017-06-27
|
| Last Update Posted: |
2017-06-27
|
| Locations: |
University of Michigan Hospital Department of Radiology, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02467075
|
