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
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 28, 2015
May 1, 2015
6.2 years
March 25, 2009
May 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Development of acute renal failure
28 days
Secondary Outcomes (2)
28 day-mortality
28 days
Decrease on plasma oxidative damage and inflammatory parameters
at the end of drug infusion
Study Arms (1)
N-acetylcysteine plus deferoxamine
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients admitted to the ICU
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
São José Hospital
Criciúma, Santa Catarina, 88801250, Brazil
Related Publications (2)
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.
PMID: 27745551DERIVEDFraga 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.
PMID: 22045831DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 25, 2009
First Posted
March 27, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 28, 2015
Record last verified: 2015-05