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N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870883
First Posted: March 27, 2009
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
  Purpose
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.

Condition Intervention Phase
Hypotension Acute Renal Failure Drug: N-acetylcysteine and deferoxamine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude:

Primary Outcome Measures:
  • Development of acute renal failure [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • 28 day-mortality [ Time Frame: 28 days ]
  • Decrease on plasma oxidative damage and inflammatory parameters [ Time Frame: at the end of drug infusion ]

Enrollment: 81
Study Start Date: March 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine plus deferoxamine Drug: N-acetylcysteine and deferoxamine
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870883


Locations
Brazil
São José Hospital
Criciuma, SC, Brazil, 88801250
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Conselho Nacional de Desenvolvimento Científico e Tecnológico
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Dal Pizzol, MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
ClinicalTrials.gov Identifier: NCT00870883     History of Changes
Other Study ID Numbers: FR208621
First Submitted: March 25, 2009
First Posted: March 27, 2009
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Renal Insufficiency
Hypotension
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Acetylcysteine
N-monoacetylcystine
Deferoxamine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents