Nephropathy
Conditions
Keywords
prevention, nephropathy
Brief summary
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Detailed description
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Interventions
DRUGplacebo
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
DRUGatorvastatin
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion Criteria: * Adults \> 18 years of age * undergoing coronary or peripheral angiography with or without intervention * Cr \> 1.3 mg/dL or GFR \< 60 mL/min 2.
Exclusion criteria
* end-stage renal disease on dialysis * acute renal failure * previous iodinated contrast media exposure within 7 days of study entry * history of hypersensitivity to statins * pregnancy or lactation * emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock * prisoners * patients already on maximum dose of statins * patient receiving N-acetylcysteine or sodium bicarbonate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours. | 48 hours | Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 & at 48 Hours |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.
Pre-assignment details
Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) | 0 |
| Placebo placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 & at 48 Hours
Time frame: 48 hours
Population: Participants signed consent; however, study was terminated prior to randomization