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N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00870883
Enrollment
81
Registered
2009-03-27
Start date
2009-03-31
Completion date
2015-05-31
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Hypotension

Brief summary

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.

Interventions

DRUGN-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.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Development of acute renal failure28 days

Secondary

MeasureTime frame
28 day-mortality28 days
Decrease on plasma oxidative damage and inflammatory parametersat the end of drug infusion

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026