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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Aminophylline
Hydration plus N-acetylcisteine
Sponsored by
Ospedale Misericordia e Dolce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ospedale Misericordia e Dolce

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aminophylline

Control group

Arm Description

Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine

Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine

Outcomes

Primary Outcome Measures

Incidence of Contrast-Induced Acute Kidney Injury
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
Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Full Information

First Posted
May 6, 2012
Last Updated
October 26, 2012
Sponsor
Ospedale Misericordia e Dolce
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1. Study Identification

Unique Protocol Identification Number
NCT01594489
Brief Title
Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
Official Title
Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aminophylline
Arm Type
Experimental
Arm Description
Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hydration plus N-acetylcisteine
Intervention Description
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 Outcome Measure Information:
Title
Incidence of Contrast-Induced Acute Kidney Injury
Description
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
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Adverse clinical events
Description
Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Organizational Affiliation
Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Misericordia e Dolce
City
Prato
ZIP/Postal Code
59100
Country
Italy

12. IPD Sharing Statement

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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

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