Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.

Conditions
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Oxidative Stress, Inflammation, Malnutrition

Intervention / Treatment
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* Dietary Supplement: alpha-lipoic acid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alpha-lipoic acid<br>the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube. | Dietary Supplement: alpha-lipoic acid<br>* the patients in this arm receive 900mg alpha-lipoic acid through NG tube.<br>|
| Placebo Comparator: placebo<br>the patients in this arm were received 900mg placebo through NG tube. | Drug: placebo<br>* the patients in this arm were received 900mg placebo through NG tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in ICU | number of days that patient stay in intensive care unit | day 28 | 
| mortality | percent of mortality | day 28 | 
| ventilator free days | show by days | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sequential organ failure assessment score | determine by SOFA score form | 10 days | 
| insulin resistance | measure by HOMA calculation equation | 10 days | 
| malondialdehyde | measure by spectrophotometery | 10 days | 
| total antioxidant capacity | measure by eliza kit | 10 days | 
| C reactive protein | measure by nephelometry method | 10 days | 
| interleukin-6 | measure by eliza kit | 10 days | 
| Albumin | record from routine lab data of patients in hospital | 10 days | 
| preAlbumin | by turbidimetric assay | 10 days | 
| Total lymphocyte count | record from routine lab data of patients in hospital | 10 days | 
| Mid arm circumference | measure by non flexible meter in mid arm | 10 days | 
| total protein | record from routine lab data of patients in hospital | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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length of stay in ICU, ventilator free days