N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypotension Acute Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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N-acetylcysteine plus deferoxamine

Group Type EXPERIMENTAL

N-acetylcysteine and deferoxamine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No