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

NCT00313807 | Withdrawn Phase 2 DMC

• 1 other identifier: contrst2006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contrast Nephropathy; Renal Failure

Keywords

contrast nephropathy; renal failure; Travasol

Outcome Measures

Primary Outcomes (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

  Day 0 to Day 7

Secondary Outcomes (7)

• the serum cystatin C level at 24 hours post procedure and 72 hours post procedure

  Day 0 to Day 3

• 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)

  Day 0 to Day 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

  Day 0 to Day 3

• development of heart failure or myocardial infarction within 7 days

  7 days

• need for renal replacement therapy

  7days

Study Arms (2)

1

ACTIVE COMPARATOR

Intravenous saline infusion plus amino acid infusion

Drug: Amino Acid

2

PLACEBO COMPARATOR

Intravenous saline infusion plus placebo infusion

Drug: Placebo

Interventions

Amino Acid DRUG

7% amino acid infusion

Also known as: Parenteral nutrition

1

Placebo DRUG

0.9% Saline Infusion

Also known as: Normal Saline Infusion

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Amino Acids; Parenteral Nutrition

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Karen E Yeates, MD MPH

  Assistant Professor, Queen's University - Division of Nephrology, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: November 1, 2005
• Study Completion: September 1, 2008
• Last Updated: March 11, 2015

Record last verified: 2015-03