Trial | NCT00870883  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    81
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.
Study Started
Mar 31
2009
Primary Completion
May 31
2015
Study Completion
May 31
2015
Last Update
May 28
2015
Estimate

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.

N-acetylcysteine plus deferoxamine Experimental

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
No Results Posted