ACT: The Acetylcysteine for Contrast-Induced Nephropathy Trial

Sponsor

Hospital do Coracao (Other)

Overall Status

Completed

CT.gov ID

NCT00736866

Collaborator

Medley Pharmaceutical Industry SA (Other)

2,300

Enrollment

Location

Arms

Duration (Months)

100.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Failure	Drug: Acetylcysteine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Contrast-induced nephropathy incidence [between 48 and 96 hours after angiographic procedures]

Secondary Outcome Measures

Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication [within 30 days]
Combined outcome of total mortality or dialysis indication [within 30 days]
The individual components of the combined outcome [within 30 dias]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.