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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

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Rėmėjai
Ospedale Misericordia e Dolce

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta: 09/30/2012
Pirmasis pateikimas: 05/05/2012
Numatytas registravimas pateiktas: 05/07/2012
Pirmas paskelbtas: 05/08/2012
Paskutinis atnaujinimas pateiktas: 10/25/2012
Paskutinis atnaujinimas paskelbtas: 10/29/2012
Faktinė studijų pradžios data: 12/31/2008
Numatoma pirminio užbaigimo data: 08/31/2012
Numatoma studijų užbaigimo data: 08/31/2012

Būklė ar liga

Acute Kidney Injury

Intervencija / gydymas

Drug: Aminophylline

Drug: Control group

Fazė

Fazė 4

Rankų grupės

RankaIntervencija / gydymas
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

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysAll
Priima sveikus savanoriusTaip
Kriterijai

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

Rezultatas

Pirminės rezultatų priemonės

1. Incidence of Contrast-Induced Acute Kidney Injury [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

Antrinės rezultatų priemonės

1. Adverse clinical events [1 month]

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

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