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Clinical Trial Details

Trial ID: L0008
Source ID: NCT01402219
Associated Drug: Iopamidol Injection 76%
Title: Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients
Acronym: NEIHR
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Renal Disease
Interventions: DRUG: Iopamidol injection 76%|DRUG: iodixanol
Outcome Measures: Primary: contrast-induced nephropathy, Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure, 48-72 h | Secondary: A relative increase in serum creatinine, A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure., 48-72 h|A relative increase in estimated glomerular filtration rate (eGFR), A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure, 48-72 h|An absolute increase in serum creatinine, An absolute increase in serum creatinine within 48-72 h of contrast exposure, 48-72 h|Major adverse clinical events, Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke, 1 month|Major adverse clinical events, Major adverse clinical events: death, requiring renal replacement therapy, acute myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke, 1 year|An significant increase in serum creatinine, An significant increase in serum creatinine was defined as an increase in serum creatinine of more than 1.0 mg/dl from the baseline within 48-72 h of contrast exposure, 48-72 h|Contrast-Induced Acute Kidney Injury, Contrast-Induced Acute Kidney Injury was defined as an increase in serum creatinine concentration of more than 0.3 mg/dL from the baseline value at 48 hours after administration of the contrast exposure or the need for dialysis, 48 h
Sponsor/Collaborators: Sponsor: Guangdong Provincial People's Hospital | Collaborators: First Affiliated Hospital, Sun Yat-Sen University|Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University|Nanfang Hospital, Southern Medical University|Guangzhou General Hospital of Guangzhou Military Command
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 204
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2008-11
Completion Date: 2013-05
Results First Posted:
Last Update Posted: 2013-08-28
Locations: Guangdong Cardiovascular Institute,Guangdong General Hospital, Guangzhou, Guangdong, 510100, China
URL: https://clinicaltrials.gov/show/NCT01402219