Oxidative Stress, Inflammation, Malnutrition
Conditions
Keywords
length of stay in ICU, ventilator free days
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTalpha-lipoic acid
the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
DRUGplacebo
the patients in this arm were received 900mg placebo through NG tube.
Sponsors
Shiraz University of Medical Sciences
najmeh hejazi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18; * expected length of stay more than 7 days; * using enteral feeding method during admitted to ICU
Exclusion criteria
* having the history of autoimmune disease * severe renal or liver failure * AIDS, * hepatitis; * having severe malnutrition at the admission time; * having TPN at the admission time in ICU; * extreme intolerance to enteral feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of stay in ICU | day 28 | number of days that patient stay in intensive care unit |
| mortality | day 28 | percent of mortality |
| ventilator free days | 10 days | show by days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total antioxidant capacity | 10 days | measure by eliza kit |
| C reactive protein | 10 days | measure by nephelometry method |
| interleukin-6 | 10 days | measure by eliza kit |
| Albumin | 10 days | record from routine lab data of patients in hospital |
| sequential organ failure assessment score | 10 days | determine by SOFA score form |
| Total lymphocyte count | 10 days | record from routine lab data of patients in hospital |
| Mid arm circumference | 10 days | measure by non flexible meter in mid arm |
| total protein | 10 days | record from routine lab data of patients in hospital |
| preAlbumin | 10 days | by turbidimetric assay |
| insulin resistance | 10 days | measure by HOMA calculation equation |
| malondialdehyde | 10 days | measure by spectrophotometery |
Countries
Iran
Contacts
Primary ContactNajmeh Hejazi, Ph.D
Outcome results
None listed