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Completed

NCT Number: NCT00736866

The Acetylcysteine for Contrast-Induced Nephropathy Trial

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.

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Key information

Conditions

Acute Kidney Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital do Coração

São Paulo, 04004030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylcysteine

Drug

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

Drug

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.

Primary outcomes

  1. Contrast-induced nephropathy incidence

    Time frame: between 48 and 96 hours after angiographic procedures

Secondary outcomes

  1. Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication

    Time frame: within 30 days

  2. Combined outcome of total mortality or dialysis indication

    Time frame: within 30 days

  3. The individual components of the combined outcome

    Time frame: within 30 dias

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Medley Pharmaceutical Industry SA

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2008
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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