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N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

This study is currently recruiting participants.
Verified September 2012 by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00870883
First received: March 25, 2009
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Development of acute renal failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 28 day-mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Decrease on plasma oxidative damage and inflammatory parameters [ Time Frame: at the end of drug infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: March 2009
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870883

Contacts
Contact: Felipe Dal-Pizzol, MD, PhD 55 48 34312671 piz@unesc.net
Contact: Cristiane Ritter, MD, PhD 55 48 30452985 crr@unesc.net

Locations
Brazil
São José Hospital Recruiting
Criciuma, SC, Brazil, 88801250
Principal Investigator: Felipe Dal-Pizzol, MD, PhD            
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Conselho Nacional de Desenvolvimento Científico e Tecnológico
  More Information

No publications provided by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Additional 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
Study First Received: March 25, 2009
Last Updated: September 27, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Hypotension
Acute Kidney Injury
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Deferoxamine
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
Siderophores
Iron Chelating Agents
Chelating Agents

ClinicalTrials.gov processed this record on May 23, 2013