A Phase 3 interventional study of alpha-lipoic acid and placebo in Oxidative Stress, Inflammation and Malnutrition, sponsored by najmeh hejazi. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-28.
Sponsored by najmeh hejazi · Phase 3, Interventional, and Prevention
Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with najmeh hejazi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.
Dietary Supplement: alpha-lipoic acid
the patients in this arm were received 900mg placebo through NG tube.
Drug: placebo
the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
the patients in this arm were received 900mg placebo through NG tube.
length of stay in ICU
number of days that patient stay in intensive care unit
Time frame: day 28
mortality
percent of mortality
Time frame: day 28
ventilator free days
show by days
Time frame: 10 days
sequential organ failure assessment score
determine by SOFA score form
Time frame: 10 days
insulin resistance
measure by HOMA calculation equation
Time frame: 10 days
malondialdehyde
measure by spectrophotometery
Time frame: 10 days
total antioxidant capacity
measure by eliza kit
Time frame: 10 days
C reactive protein
measure by nephelometry method
Time frame: 10 days
interleukin-6
measure by eliza kit
Time frame: 10 days
Albumin
record from routine lab data of patients in hospital
Time frame: 10 days
preAlbumin
by turbidimetric assay
Time frame: 10 days
Total lymphocyte count
record from routine lab data of patients in hospital
Time frame: 10 days
Mid arm circumference
measure by non flexible meter in mid arm
Time frame: 10 days
total protein
record from routine lab data of patients in hospital
Time frame: 10 days
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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