Using alpha-lipoic acid to treat critically ill patients with sepsis
Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis
This study is testing if alpha-lipoic acid can help critically ill patients with sepsis recover better than those who receive a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Damanhour University Academic / other |
| Locations | 1 site (Damanhūr, Elbehairah) |
| Trial ID | NCT06661993 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of alpha-lipoic acid (ALA) in critically ill patients diagnosed with sepsis. A total of 60 patients will be enrolled at Damanhur National Medical Institute and randomly assigned to receive either ALA or a placebo for seven days. The study aims to assess various outcomes, including ICU and hospital mortality, length of stay, and changes in inflammatory markers. Ethical approval has been obtained, and informed consent will be required from all participants or their relatives.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are diagnosed with sepsis during their ICU stay and can receive oral or enteral medication.
Not a fit: Patients diagnosed with septic shock, pregnant or lactating women, and those currently taking other antioxidant medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and reduce complications in critically ill septic patients.
How similar studies have performed: While the use of alpha-lipoic acid in sepsis is not widely tested, similar antioxidant approaches have shown promise in other critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Damanhūr, Elbehairah
- Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes. — Damanhūr, Elbehairah, Egypt (Recruiting)
Study contacts
- Study coordinator: Rehab H Werida, Ass. Prof.
- Email: rehabwrieda@pharm.dmu.edu.eg
- Phone: 01005359968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.