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Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage

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ClinicalTrials.gov Identifier: NCT00313807
Recruitment Status : Withdrawn (Abandoned due to lack of recruitment Oct 2006)
First Posted : April 12, 2006
Last Update Posted : March 11, 2015
Sponsor:
Information provided by:
Queen's University

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, 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.


Condition or disease Intervention/treatment Phase
Contrast Nephropathy Renal Failure Drug: Amino Acid Drug: Placebo Phase 2

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 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2005
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 1
Intravenous saline infusion plus amino acid infusion
Drug: Amino Acid
7% amino acid infusion
Other Name: Parenteral nutrition

Placebo Comparator: 2
Intravenous saline infusion plus placebo infusion
Drug: Placebo
0.9% Saline Infusion
Other Name: Normal Saline Infusion




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. the serum cystatin C level at 24 hours post procedure and 72 hours post procedure [ Time Frame: Day 0 to Day 3 ]
  2. the number of patients with a peak increase in serum creatinine concentration of at least 44.1 umol/L between day 0 and day 3 (72 hours) [ Time Frame: Day 0 to Day 3 ]
  3. the number of patients with a peak increase in serum creatinine concentration of at least 88.4 μmol per liter between day 0 and day 3 (72 hours) post-catheterization [ Time Frame: Day 0 to Day 3 ]
  4. development of heart failure or myocardial infarction within 7 days [ Time Frame: 7 days ]
  5. need for renal replacement therapy [ Time Frame: 7days ]
  6. death at 48 hours, 7 days, or 14 days post-catheterization [ Time Frame: 14 days ]
  7. number of hospital days after catheterization [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313807


Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Karen E Yeates, MD MPH Assistant Professor, Queen's University - Division of Nephrology, Department of Medicine

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Responsible Party: Dr Karen E. Yeates, Department of Medicine Queen's University
ClinicalTrials.gov Identifier: NCT00313807     History of Changes
Other Study ID Numbers: contrst2006
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Queen's University:
contrast nephropathy
renal failure
Travasol

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases
Amino-acid, glucose, and electrolyte solution
Parenteral Nutrition Solutions
Pharmaceutical Solutions