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

10. marts 2015 opdateret af: Queen's University

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Intravenous saline infusion plus amino acid infusion
Medicin: Amino Acid
7% amino acid infusion
Andre navne:
  • Parenteral nutrition
Placebo komparator: 2
Intravenous saline infusion plus placebo infusion
Medicin: Placebo
0.9% Saline Infusion
Andre navne:
  • Normal Saline Infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Day 0 to Day 7
Day 0 to Day 7

Sekundære resultatmål

Resultatmål
Tidsramme
the serum cystatin C level at 24 hours post procedure and 72 hours post procedure
Tidsramme: Day 0 to Day 3
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)
Tidsramme: Day 0 to Day 3
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
Tidsramme: Day 0 to Day 3
Day 0 to Day 3
development of heart failure or myocardial infarction within 7 days
Tidsramme: 7 days
7 days
need for renal replacement therapy
Tidsramme: 7days
7days
death at 48 hours, 7 days, or 14 days post-catheterization
Tidsramme: 14 days
14 days
number of hospital days after catheterization
Tidsramme: 7 days
7 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Queen's University

Efterforskere

  • Ledende efterforsker: Karen E Yeates, MD MPH, Assistant Professor, Queen's University - Division of Nephrology, Department of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2005

Studieafslutning

1. september 2008

Datoer for studieregistrering

Først indsendt

11. april 2006

Først indsendt, der opfyldte QC-kriterier

11. april 2006

Først opslået (Skøn)

12. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • contrst2006

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