Alpha-lipoic Acid in Critically Ill Patients With Sepsis

Damanhour University

Status: Completed

Conditions: Sepsis

Treatments: Dietary Supplement: Alpha-lipoic acid; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06661993

alpha-lipoic acid in sepsis

Details and patient eligibility

About

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 .

Full 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. Outcomes 1. The primary outcome ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) 2. The secondary outcome are as follows: A. 28-day all-cause mortality B. change in inflammatory markers such as CRP , IL6, and TNF Alpha and may be measured glycocalyx degradation markers such as syndecan 1.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

control group: 40 septic patients will receive placebo daily for seven days.

Treatment:

Other: Placebo

ALA group

Active Comparator group

Description:

ALA group: 40 septic patients will be given 1800 mg orally or via a nasogastric tube daily for seven days .

Treatment:

Dietary Supplement: Alpha-lipoic acid