The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)

This study has been completed.
Sponsor:
Collaborator:
Medley Pharmaceutical Industry SA
Information provided by:
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT00736866
First received: August 14, 2008
Last updated: July 8, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Acute Kidney Failure
Drug: Acetylcysteine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Contrast-induced nephropathy incidence [ Time Frame: between 48 and 96 hours after angiographic procedures ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • Combined outcome of total mortality or dialysis indication [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • The individual components of the combined outcome [ Time Frame: within 30 dias ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2300
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736866

Locations
Brazil
Hospital do Coração
Sao Paulo, Brazil, 04004030
Sponsors and Collaborators
Hospital do Coracao
Medley Pharmaceutical Industry SA
Investigators
Principal Investigator: Eduardo Sousa, PhD Hospital do Coracao
  More Information

No publications provided by Hospital do Coracao

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otavio Berwanger, Hospital do Coracao
ClinicalTrials.gov Identifier: NCT00736866     History of Changes
Other Study ID Numbers: IEP- HCor 001/08
Study First Received: August 14, 2008
Last Updated: July 8, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital do Coracao:
acetylcysteine
contrast-induced nephropathy
angiography
angioplasty with or without Stent

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Acute Kidney Injury
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 22, 2014