| Trial ID: | L0194 |
| Source ID: | NCT00823628
|
| Associated Drug: |
Contrast Agent (Iopromide)
|
| Title: |
Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Insufficiency|Coronary Angiography
|
| Interventions: |
DRUG: contrast agent (iopromide)|DRUG: contrast agent (iodixanol)
|
| Outcome Measures: |
Primary: Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L), days 1 and 2 | Secondary: proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine, days 1 and 2
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
420
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2010-07-07
|
| Locations: |
Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00823628
|
