Alpha-lipoic Acid in Critically Ill Patients With Sepsis
Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis
Sponsor: Damanhour University
A observational or N/A phase clinical study on Sepsis, this trial is completed. The trial is conducted by Damanhour University and has accumulated 3 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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).
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).
Status Flow
Change History
3 versions recorded-
Apr 23, 2026 — Present [daily]
Completed
Phase: NA → None
-
Jan 2026 — Apr 2026 [monthly]
Completed NA
Status: Recruiting → Completed
-
Nov 2024 — Jan 2026 [monthly]
Recruiting NA
First recorded
Oct 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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 .
Contact Information
- Damanhour University
- Tanta University
For direct contact, visit the study record on ClinicalTrials.gov .