Alpha-lipoic Acid in Critically Ill Patients With Sepsis

Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis

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 .

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).

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