Status:
WITHDRAWN
Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage
Lead Sponsor:
Queen's University
Conditions:
Contrast Nephropathy
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acu...
Detailed Description
Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Retrospective studies have confirmed that...
Eligibility Criteria
Inclusion
- Greater then 18 years of age
- Referral for coronary angiography
- Type 1 or type 2 diabetic requiring insulin or oral hypoglycemic agents
- Stable serum creatinine concentration (140 to 300 μmol per liter for men or 125 to 300 μmol per liter for women or a creatinine clearance not greater than 60 ml/min (as calculated by Cockcroft-Gault equation)
- Non diabetic subjects with a stable serum creatinine concentration of 160 to 300 µmol per liter for men and 140 to 300 µmol per liter for women.
- Stable renal function defined as no documented rise or fall in serum creatinine by more then 44 umol/L in the preceding 2 weeks
Exclusion
- Refusal or inability to give consent
- Pregnant
- Non-elective coronary angiography
- Recent administration (within 21 days) of iodinated intravenous contrast dye
- Recent administration (within 21 days) of non-steroidal anti-inflammatory drugs (excluding aspirin), aminoglycoside antibiotics or chemotherapeutic agents
- Severe/unstable diabetics requiring emergency room or inpatient therapy in the previous 21 days
- Compensated or decompensated hepatic failure
- Renal transplant
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00313807
Start Date
November 1 2005
End Date
September 1 2008
Last Update
March 11 2015
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