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CompletedNCT00870883Updated May 28, 2015

N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

A Phase 2 interventional study of N-acetylcysteine and deferoxamine in Hypotension and Acute Renal Failure, sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypotension
  • Acute Renal Failure
03

In context

Hypotension

1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's enrollment of 81 is close to the median of 80 across 686 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    N-acetylcysteine plus deferoxamine

    Drug: N-acetylcysteine and deferoxamine

Interventions

  • DrugN-acetylcysteine and deferoxamine

    Drug pages: Acetylcysteine · 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.

06

What researchers measure

Primary outcomes

  1. Development of acute renal failure

    Time frame: 28 days

Secondary outcomes

  1. 28 day-mortality

    Time frame: 28 days

  2. Decrease on plasma oxidative damage and inflammatory parameters

    Time frame: at the end of drug infusion

07

Study locations

1 site
  • São José Hospital
    Criciúma, Santa Catarina 88801250, Brazil
08

References and documents

Publications

  • Fraga CM, Tomasi CD, Damasio DC, Vuolo F, Ritter C, Dal-Pizzol F. N-acetylcysteine plus deferoxamine for patients with prolonged hypotension does not decrease acute kidney injury incidence: a double blind, randomized, placebo-controlled trial. Crit Care. 2016 Oct 17;20(1):331. doi: 10.1186/s13054-016-1504-1. PubMed 27745551 ↗
  • Fraga CM, Tomasi CD, Biff D, Topanotti MF, Felisberto F, Vuolo F, Petronilho F, Dal-Pizzol F, Ritter C. The effects of N-acetylcysteine and deferoxamine on plasma cytokine and oxidative damage parameters in critically ill patients with prolonged hypotension: a randomized controlled trial. J Clin Pharmacol. 2012 Sep;52(9):1365-72. doi: 10.1177/0091270011418657. Epub 2011 Nov 1. PubMed 22045831 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2009, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2009
First posted
Mar 27, 2009
Start
Mar 2009
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
May 28, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00870883
Lead sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Felipe Dal Pizzol (MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude) — Principal investigator
First posted
Mar 27, 2009
Start date
Mar 2009
Primary completion
May 2015
Completion
May 2015
Last update
May 28, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Acetylcysteine · Deferoxamine

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Hypotension →

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Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

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