Alpha-lipoic Acid in Critically Ill Patients With Sepsis

Not Applicable

Recruiting

• Conditions: Sepsis

• Registration Number: NCT06661993
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) Score	1 week	The SOFA score is a composite score based on the degree of dysfunction in six organ systems-respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ dysfunction scores from 0 to 4, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention. The higher the SOFA score, the higher the likely mortality.
ICU and hospital stay	1 month	Duration (days)

Secondary Outcome Measures

Name	Time	Method
Syndecan 1 (ug/dl)	1 Week	glycocalyx degradation marker
CRP (ug/dl)	1 Week	Inflammatory marker

Trial Locations

Locations (1)

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.; 🇪🇬 Damanhūr, Elbehairah, Egypt