Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

NCT ID: NCT01160627

Last Updated: 2013-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-03-31

Brief Summary

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OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.

Patients will be randomised to:

1. Standard treatment
2. Standard treatment + acetylcystein for 2 days
3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours

Detailed Description

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Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard treatment

Hydration

Group Type ACTIVE_COMPARATOR

Hydration

Intervention Type OTHER

Saline hydration

Combined Acetylcystein and Sodium Bicarbonat

Group Type ACTIVE_COMPARATOR

Combined Acetylcystein and Sodium Bicarbonate

Intervention Type DRUG

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days

Sodium Bicarbonate

Group Type ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type DRUG

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours

Acetylcystein for 2 days

Standard treatment + acetylcystein for 2 days

Group Type ACTIVE_COMPARATOR

Acetylcysteine

Intervention Type DRUG

Acetylcystein tablets for 2 days

Interventions

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Hydration

Saline hydration

Intervention Type OTHER

Acetylcysteine

Acetylcystein tablets for 2 days

Intervention Type DRUG

Sodium bicarbonate

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours

Intervention Type DRUG

Combined Acetylcystein and Sodium Bicarbonate

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* STEMI patients treated with primary PCI

Exclusion Criteria

* Cardiogenic shock
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lisette Okkels Jensen

MD DMSci PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per Thayssen, MD DMSci

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.

Reference Type DERIVED
PMID: 24714489 (View on PubMed)

Other Identifiers

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CIN in STEMI

Identifier Type: -

Identifier Source: org_study_id

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