Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
| Zuletzt überprüft: | 09/30/2012 |
| Zuerst eingereicht: | 05/05/2012 |
| Geschätzte Einschreibung eingereicht: | 05/07/2012 |
| Zuerst veröffentlicht: | 05/08/2012 |
| Letztes eingereichtes Update: | 10/25/2012 |
| Letztes Update veröffentlicht: | 10/29/2012 |
| Tatsächliches Startdatum der Studie: | 12/31/2008 |
| Geschätztes primäres Abschlussdatum: | 08/31/2012 |
| Voraussichtliches Abschlussdatum der Studie: | 08/31/2012 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Aminophylline
Drug: Control group
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: Aminophylline Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine | Drug: Aminophylline 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 |
| Active Comparator: Control group Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine | Drug: Control group 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 |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 |
Ergebnis
Primäre Ergebnismaße
1. Incidence of Contrast-Induced Acute Kidney Injury [3 days]
Sekundäre Ergebnismaße
1. Adverse clinical events [1 month]
