Sepsis
Conditions
Brief summary
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 .
Detailed description
1. Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhour University & Ethics committee of Damanhur National Medical National Institute. 2. All participants or their relatives should agree to take part in this clinical study and will provide informed consent. 3. 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 . 4. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 5. Results, conclusion, discussion and recommendations will be given. 6. The primary outcomes were evaluated as follows: organ dysfunction via the SOFA score, systemic inflammation via IL-6 and CRP, oxidative stress via malondialdehyde (MDA), endothelial glycocalyx integrity via syndecan-1, and 28-day mortality as clinical outcome. Secondary outcomes included 90-day survival, the number of ventilator-free days within 28 days, the duration of vasopressor therapy, and both ICU and overall hospital length of stay. Exploratory outcomes included changes in kidney function (serum creatinine) and liver function (ALT, AST).
Interventions
OTHERPlacebo
placebo film-coated tablet orally or via a nasogastric tube for seven days .
DIETARY_SUPPLEMENTAlpha-lipoic acid
Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days .
Sponsors
Damanhour University
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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 .
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who will be diagnosed with sepsis or develop sepsis during their ICU length of stay * Age 18 year and older * Patient able to receive oral or enteral medication
Exclusion criteria
* Patients who will be diagnosed with septic shock * Female patients who are pregnant or lactating. * Participation in another clinical trial. * Current treatment with other medications that have antioxidant effects, such as vitamin C and vitamin E. * Allergy to LA or similar active agents (e.g., vitamin B), or previous intolerance to the recommended dose of LA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Score | 1 week | 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. |
| CRP (mg/L) | 1 Week | Inflammatory marker |
| Syndecan 1 (ng/mL) | 1 Week | glycocalyx degradation marker |
| IL-6 (pg/mL) | 1 Week | Inflammatory marker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU and hospital stay | 28 days | Duration (days) |
| ventilator-free days within 28 days | 28 days | Duration (days) |
| the duration of vasopressor therapy | 1 Week | Duration (days) |
Countries
Egypt
Contacts
STUDY_CHAIRTarek Mostafa, Prof.
Tanta University
Outcome results
None listed