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

Hospital do Coracao1 site in 1 country2,300 target enrollmentAugust 2008

ConditionsAcute Kidney Failure

InterventionsAcetylcysteine Placebo

DrugsAcetylcysteine Placebo

Overview

Phase: Phase 3
Intervention: Acetylcysteine
Conditions: Acute Kidney Failure
Sponsor: Hospital do Coracao
Enrollment: 2300
Locations: 1
Primary Endpoint: Contrast-induced nephropathy incidence
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital do Coracao

Eligibility Criteria

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.

Arms & Interventions

Acetylcysteine

Intervention: Acetylcysteine

Control

Intervention: Placebo

Outcomes

Primary Outcomes

Contrast-induced nephropathy incidence

Time Frame: between 48 and 96 hours after angiographic procedures

Secondary Outcomes

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)