The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)

July 8, 2010 updated by: Hospital do Coracao

A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy

The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.

Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04004030
        • Hospital do Coracao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

At least one of the following criteria:

  • Aged more than 70 years-old
  • Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
  • Diabetes mellitus
  • Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
  • Shock or intra-aortic balloon pump use
  • Urgency or emergency procedures

Exclusion Criteria:

  • Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
  • Patients in dialysis
  • Previous inclusion in this trial
  • Patient refusal to informed consent
  • Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Drug: Placebo
Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
Experimental: Acetylcysteine
Drug: Acetylcysteine
Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contrast-induced nephropathy incidence
Time Frame: between 48 and 96 hours after angiographic procedures
between 48 and 96 hours after angiographic procedures

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication
Time Frame: within 30 days
within 30 days
Combined outcome of total mortality or dialysis indication
Time Frame: within 30 days
within 30 days
The individual components of the combined outcome
Time Frame: within 30 dias
within 30 dias

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Collaborators

Medley Pharmaceutical Industry SA

Investigators

  • Principal Investigator: Eduardo Sousa, PhD, Hospital do Coracao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEP- HCor 001/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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