Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage
|First Received Date ICMJE||April 11, 2006|
|Last Updated Date||June 13, 2008|
|Start Date ICMJE||November 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||to assess if the infusion of amino acids will help prevent kidney damage that can occur when angiographic dye is used to perform a cardiac catheterization [ Time Frame: Day 0 to Day 7 ] [ Designated as safety issue: Yes ]|
|Original Primary Outcome Measures ICMJE
||Peak increase in serum creatinine concentration between day 0 (day of contrast administration) and day 3 (approximately 48 hours post contrast administration)|
|Change History||Complete list of historical versions of study NCT00313807 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage|
|Official Title ICMJE||CoNTRST - Contrast Nephropathy and Travasol for Renal Safety Trial: Intravenous Amino Acid Infusion for the Prevention of Contrast-Mediated Acute Renal Failure Following Coronary Catheterization|
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, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk.
The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF.
We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.
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 at least 60% of contrast-associated nephropathy occurs in subjects with chronic renal failure. The incidence approaches 20% in those with a baseline creatinine greater than 198.2 μmol per liter (2.25 mg/dL). Diabetes, in the absence of renal insufficiency, does not appear to confer added risk; however diabetic patients with chronic renal failure are at highest risk. It is particularly this group that develops oliguric renal failure requiring temporary or permanent renal replacement therapy. In diabetic patients with mild to moderate renal failure, the incidence of contrast-associated nephropathy has been reported to be between 9% and 40% however a greater then 50% incidence has been noted in diabetic patients with more severely impaired renal function.
It is hypothesized that the renal toxicity of contrast medium is related to local vasoconstriction. We hypothesize that the protein-stimulated rise in effective RPF and GFR might counteract this intrarenal vasoconstriction and reduce the toxicity of contrast medium in high-risk patients with diabetes. We propose that an infusion of amino acids prior to the administration of contrast dye, will increase renal plasma flow and glomerular filtration rate by approximately 20% and hasten excretion of the contrast agent thereby protecting high-risk patients from contrast nephropathy.
This is a double-blind, randomized, placebo-controlled trial evaluating the effectiveness of an amino-acid infusion in addition to usual therapy (intravenous normal saline infusion) for the prevention of renal dysfunction following angiographic dye administration during coronary angiography in a high risk group of patients with chronic renal insufficiency.
Comparison: Primary and secondary outcomes in patients receiving intravenous amino acid infusion compared to placebo group receiving intravenous normal saline.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||September 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00313807|
|Other Study ID Numbers ICMJE||contrst2006|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Dr Karen E. Yeates, Department of Medicine Queen's University|
|Study Sponsor ICMJE||Queen's University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Queen's University|
|Verification Date||June 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP