- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870883
N-acetylcysteine Plus Deferoxamine for Patients With Hypotension
May 27, 2015 updated by: Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SC
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Criciuma, SC, Brazil, 88801250
- São José Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: N-acetylcysteine plus 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of acute renal failure
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28 day-mortality
Time Frame: 28 days
|
28 days
|
Decrease on plasma oxidative damage and inflammatory parameters
Time Frame: at the end of drug infusion
|
at the end of drug infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
March 25, 2009
First Submitted That Met QC Criteria
March 25, 2009
First Posted (Estimate)
March 27, 2009
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Acute Kidney Injury
- Hypotension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Free Radical Scavengers
- Expectorants
- Iron Chelating Agents
- Siderophores
- Acetylcysteine
- N-monoacetylcystine
- Deferoxamine
Other Study ID Numbers
- FR208621
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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