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| Name | Class |
|---|---|
| Shiraz University of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha-lipoic acid | Experimental | the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube. |
|
| placebo | Placebo Comparator | the patients in this arm were received 900mg placebo through NG tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha-lipoic acid | Dietary Supplement | the patients in this arm receive 900mg alpha-lipoic acid through NG tube. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| sequential organ failure assessment score | determine by SOFA score form | 10 days |
| insulin resistance | measure by HOMA calculation equation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Najmeh Hejazi, Ph.D | Contact | n20hejazi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Najmeh Hejazi, Ph.D | Shiraz University of Medical Sciences,Nutrition department | Principal Investigator |
| Zohreh Mazloom, PhD | Shiraz University of Medical Sciences, Faculty of Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz University of Medical Sciences, Department of Nutrition | Recruiting | Shiraz | Fars | 7157617516 | Iran |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| placebo | Drug | the patients in this arm were received 900mg placebo through NG tube. |
|
| 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 |
| Farid Zand, MD | Shiraz University of Medical Sciences, anesthesiology and critical care research center | Study Chair |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |