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| Name | Class |
|---|---|
| Tanta University | OTHER |
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Evaluate the of effect of alpha-lipoic acid in critically ill septic patients. 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | control group: 40 septic patients will receive placebo daily for seven days. |
|
| ALA group | Active Comparator | ALA group: 40 septic patients will be given 1800 mg for seven days . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | placebo film-coated tablet orally or via a nasogastric tube for seven days . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Score | The SOFA score is a composite score based on the degree of dysfunction in six organ systems-respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ dysfunction scores from 0 to 4, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention. The higher the SOFA score, the higher the likely mortality. | 1 week |
| CRP (mg/L) | Inflammatory marker | 1 Week |
| Syndecan 1 (ng/mL) | glycocalyx degradation marker | 1 Week |
| IL-6 (pg/mL) | Inflammatory marker | 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital stay | Duration (days) | 28 days |
| ventilator-free days within 28 days | Duration (days) | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Mostafa, Prof. | Tanta University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes. | Damanhūr | Elbehairah | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31221283 | Background | Rahimlou M, Asadi M, Banaei Jahromi N, Mansoori A. Alpha-lipoic acid (ALA) supplementation effect on glycemic and inflammatory biomarkers: A Systematic Review and meta- analysis. Clin Nutr ESPEN. 2019 Aug;32:16-28. doi: 10.1016/j.clnesp.2019.03.015. Epub 2019 May 2. | |
| 30754087 | Background | Thompson K, Venkatesh B, Finfer S. Sepsis and septic shock: current approaches to management. Intern Med J. 2019 Feb;49(2):160-170. doi: 10.1111/imj.14199. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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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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80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into two groups (40 patients each): control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric/orogastric tube of ALA daily for seven days .
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| Alpha-lipoic acid | Dietary Supplement | Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days . |
|
|
| the duration of vasopressor therapy | Duration (days) | 1 Week |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |