Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Sponsor

Ospedale Misericordia e Dolce (Other)

Overall Status

Completed

CT.gov ID

NCT01594489

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Aminophylline Drug: Hydration plus N-acetylcisteine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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: Hydration plus N-acetylcisteine 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

Arm

Intervention/Treatment

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: Hydration plus N-acetylcisteine

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Misericordia e Dolce	Prato		Italy	59100

Sponsors and Collaborators

Ospedale Misericordia e Dolce

Investigators

Principal Investigator: Mauro Maioli, MD, Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mauro Maioli, Medical Doctor, Ospedale Misericordia e Dolce

ClinicalTrials.gov Identifier:

NCT01594489

Other Study ID Numbers:

Prato0704

First Posted:

May 9, 2012

Last Update Posted:

Oct 30, 2012

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Acute Kidney Injury

Myocardial Infarction

Infarction

Aminophylline

Study Results

No Results Posted as of Oct 30, 2012