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Completed

NCT Number: NCT01594489

Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Misericordia e Dolce

Prato, 59100, Italy

About this study

Due to the clinical relevance of contrast acute kidney injury a large number of prophylactic procedures have been investigated. N-acetylcysteine and hydration with sodium bicarbonate are proved to be protective against contrast acute kidney injury. The adenosine-mediated afferent arteriolar vasoconstriction is a possible pathomechanism of renal impairment by contrast agent. It has been observed that aminophylline/theophylline, competitive adenosine antagonists, improves oxygen delivery to ischemic tissue, diminishes oxidative damage to renal tissue and may also scavenge free radicals.

The purpose of this study was to investigated whether the additional therapy with adenosine antagonist aminophylline reduces the incidence of contrast renal damage in high risk patients who have acute myocardial infarction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more than 1 mm in at least two contiguous leads of the electrocardiogram

Exclusion criteria

  • contrast medium administration within the previous 10 days,
  • end-stage renal failure requiring dialysis,
  • refusal to give informed consent

Treatment and study plan

Aminophylline

Drug
  • 200 mg of aminophylline administrated intravenously as a short infusion, started in emergency department, before primary angioplasty and contrast medium administration
  • Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
  • N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Hydration plus N-acetylcisteine

Drug
  • Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
  • N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Primary outcomes

  1. Incidence of Contrast-Induced Acute Kidney Injury

    Time frame: 3 days

    Contrast-Induced Acute Kidney Injury is defined as an increase in serum creatinine of >=25% or 0.5 mg/dL over the baseline value within 3 days after the administration of the contrast medium

Secondary outcomes

  1. Adverse clinical events

    Time frame: 1 month

    Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 9, 2012
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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