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Completed

NCT Number: NCT00870883

N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

São José Hospital

Criciúma, Santa Catarina, 88801250, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients admitted to the ICU
  • Presenting hypothesion (MAP < 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion

Exclusion criteria

  • Age lower than 18 years old
  • Chronic renal failure
  • A known history of allergy to any of the study drugs
  • Using n-acetylcysteine to paracetamol overdose
  • Pregnant women
  • Patients who used iodinated contrast medium
  • Hemoglobin less than 6.5 mg/dl
  • Cancer patients

Treatment and study plan

N-acetylcysteine and deferoxamine

Drug

N-acetylcysteine bolus dose of 50mg/kg/4h, by a manutention of 100mg/kg/day during 2 days and deferoxamine single dose of 1g administered 15mg/kg/h.

Primary outcomes

  1. Development of acute renal failure

    Time frame: 28 days

Secondary outcomes

  1. 28 day-mortality

    Time frame: 28 days

  2. Decrease on plasma oxidative damage and inflammatory parameters

    Time frame: at the end of drug infusion

Sponsors and collaborators

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2009
Registry last updated
May 28, 2015

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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