The Acetylcysteine for Contrast-Induced Nephropathy Trial
Information source: Hospital do Coracao
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Kidney Failure
Intervention: Acetylcysteine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hospital do Coracao Official(s) and/or principal investigator(s):
Eduardo Sousa, PhD, Principal Investigator, Affiliation: Hospital do Coracao
Overall contact:
Otavio Berwanger, PhD, Phone: +551130536611, Ext: 8201, Email: otavioberwanger@yahoo.com.br
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.
Clinical Details
Official title: A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-Induced Nephropathy
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Contrast-induced nephropathy incidence
Secondary outcome: Combined outcome of total mortality, dialysis indication or basal serum creatinine duplicationCombined outcome of total mortality or dialysis indication The individual components of the combined outcome
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Otavio Berwanger, PhD, Phone: +551130536611, Ext: 8201, Email: otavioberwanger@yahoo.com.br
Hospital do Coração, Sao Paulo 04004030, Brazil; Recruiting
Otavio Berwanger, PhD, Phone: +551130536611, Ext: 8201, Email: otavioberwanger@yahoo.com.br
Anna Buehler, PharmD, Phone: +551130536611, Ext: 8209, Email: abuehler@hcor.com.br
Dr Adriana Moreira, MD, Sub-Investigator
Additional Information
Starting date: August 2008
Ending date: April 2010
Last updated: June 9, 2009
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