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N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Primary Purpose

Hypotension, Acute Renal Failure

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
N-acetylcysteine and deferoxamine
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • São José Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

N-acetylcysteine plus deferoxamine

Arm Description

Outcomes

Primary Outcome Measures

Development of acute renal failure

Secondary Outcome Measures

28 day-mortality
Decrease on plasma oxidative damage and inflammatory parameters

Full Information

First Posted
March 25, 2009
Last Updated
May 27, 2015
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT00870883
Brief Title
N-acetylcysteine Plus Deferoxamine for Patients With Hypotension
Official Title
Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Acute Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine plus deferoxamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine and deferoxamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Development of acute renal failure
Time Frame
28 days
Secondary Outcome Measure Information:
Title
28 day-mortality
Time Frame
28 days
Title
Decrease on plasma oxidative damage and inflammatory parameters
Time Frame
at the end of drug infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
São José Hospital
City
Criciuma
State/Province
SC
ZIP/Postal Code
88801250
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27745551
Citation
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.
Results Reference
derived
PubMed Identifier
22045831
Citation
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.
Results Reference
derived

Learn more about this trial

N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

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