N-acetylcysteine Plus Deferoxamine for Patients With Hypotension

Hypotension Clinical Trial

Official title:

Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870883
• Other study ID #: FR208621
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2009
• Last updated: May 27, 2015
• Start date: March 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Hypotension
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Brazil	São José Hospital	Criciuma	SC

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of acute renal failure		28 days	No
Secondary	28 day-mortality		28 days	No
Secondary	Decrease on plasma oxidative damage and inflammatory parameters		at the end of drug infusion	No