Clinical trial NCT06661993: Alpha-lipoic Acid in Critically Ill Patients With Sepsis
Official title: Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into two groups (30 patients each): 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 .
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate the of effect of alpha-lipoic acid in critically ill septic patients. 60 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. 60 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.

Eligibility 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

Primary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 1 week
measure: ICU and hospital stay
timeFrame: 1 month
Secondary outcomes:
measure: Syndecan 1 (ug/dl)
timeFrame: 1 Week
measure: CRP (ug/dl)
timeFrame: 1 Week
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
state: Elbehairah
Study officials:
affiliation: Tanta University
name: Tarek Mostafa, Prof.
role: STUDY_CHAIR
References:
citation: Rahimlou M, Asadi M, Banaei Jahromi N, Mansoori A. Alpha-lipoic acid (ALA) supplementation effect on glycemic and inflammatory biomarkers: A Systematic Review and meta- analysis. Clin Nutr ESPEN. 2019 Aug;32:16-28. doi: 10.1016/j.clnesp.2019.03.015. Epub 2019 May 2.
citation: Thompson K, Venkatesh B, Finfer S. Sepsis and septic shock: current approaches to management. Intern Med J. 2019 Feb;49(2):160-170. doi: 10.1111/imj.14199.