The general goal of study is improvement in tolerance of oxygenation by reduction of one of the marker of oxidative stress. 20 mechanically ventilated mechanically ventilated critically ill patients who undergo mechanical ventilation for 3 days with 50% Fio2 and have as stable hemodynamic and acceptable vital organ function are enrolled and receive deferasirox 1500 mg for 3 days. the primary outcome of study are oxidative stress markers and iron-related factor , mortality rate and organ function that will be assessed by APACHE 2 and SOFA respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138709181497N1
Registration date:2010-03-21, 1389/01/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-03-21, 1389/01/01
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Sciences Research Center of pharmacy faculty of Tehran University of Medical Sciences and Health services
Expected recruitment start date
2009-03-11, 1387/12/21
Expected recruitment end date
2010-05-01, 1389/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of defrasirox on inflammatory biomarkers in broncgoalveolar lavage fluid of mechnically ventilated patients
Public title
Role of iron chelator in oxidative stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mechanically ventilated patients, Fio2 more than 50% for at least 3 days and PEEP equal to 5, Ability to receive drug by oral route Exclusion criteria: Dissatisfaction of patients or family, other diseases that cause pulmonary edema such as CHF, pulmonary hemorrhage, age less than 18, patients who are NPO, severe liver failure (ALT, AST>5 times of baseline), moderate to severe renal failure (Cr >1mg/dl or u/o <0.5cc/kg/hr or dialysis), patients who are in shock (PH <7.2 , Pao2/Fio2 <100 , MAP< 65), receiving other anti-inflammatory drugs such as NAC or corticosteroids, history of leukemia, BMT, thalassemia, iron deficiency anemia, receiving iron chelator drugs during 3 months prior to the study, receiving chemotherapy or immunosuppressive drugs during 3 months prior to the study, Level of ferritin less than 30 mcg/L, Grade 2-3 of heart block, QT prolongation, positive viral markers such as HIV, HBV , HCV, WBC<3000, ANC<1500, PLT<50000, Ejection Fraction <55%
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services associated ethics committee
Street address
6th floor,central organisation of tums,ghods Ave, keshavarz Blvd
City
Tehran
Postal code
Approval date
2009-02-10, 1387/11/22
Ethics committee reference number
970/130/ص
Health conditions studied
1
Description of health condition studied
critically ill mechanically ventilated patients
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
8-isoprostane in plasma and BAL fluid
Timepoint
0 and 72 hour after drug administration
Method of measurement
human elisa kit
2
Description
carbonyl protein in plasma and BAL fluid
Timepoint
0 and 72 hour after drug
Method of measurement
human elisa kit
3
Description
8-oxoguanin in plasma and BAL fluid
Timepoint
0 and 72 hour after drug
Method of measurement
human elisa kit
4
Description
ferritin in plasma and BAL fluid
Timepoint
0 and 72 hour after drug
Method of measurement
human elisa kit
5
Description
transferrin in plasma and BAL fluid
Timepoint
0 and 72 hour after drug
Method of measurement
human elisa kit
6
Description
free iron in plasma and BAL fluid
Timepoint
0 and 72 hour after drug
Method of measurement
spectroscopy method
Secondary outcomes
1
Description
mortality rate
Timepoint
from the time of treatment until 1 week
Method of measurement
APACHE2
2
Description
Assesment of organ failure
Timepoint
from the time of treatment until 1 week
Method of measurement
SOFA
Intervention groups
1
Description
Deferasirox 1500 mg(po) for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
general intensive care unit of sina teaching hospital affilated to Tehran University Of Medical Scie
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Science Research Center of Pharmacy Faculty of Tehran University Of Medical Sciences