NCT06661993

Alpha-lipoic Acid in Critically Ill Patients With Sepsis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Placebo	placebo film-coated tablet orally or via a nasogastric tube for seven days .
DIETARY_SUPPLEMENT	Alpha-lipoic acid	Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days .

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2024-10-28
• Last updated: 2025-12-03

Locations

1 site across 1 country: Egypt