Alpha-lipoic Acid in Critically Ill Patients With Sepsis

NCT06661993 | Completed

• 1 other identifier: alpha-lipoic acid in sepsis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• Sequential Organ Failure Assessment (SOFA) Score

  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.

  1 week

• CRP (mg/L)

  Inflammatory marker

  1 Week

• Syndecan 1 (ng/mL)

  glycocalyx degradation marker

  1 Week

• IL-6 (pg/mL)

  Inflammatory marker

  1 Week

Secondary Outcomes (3)

• ICU and hospital stay

  28 days

• ventilator-free days within 28 days

  28 days

• the duration of vasopressor therapy

  1 Week

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

control group: 40 septic patients will receive placebo daily for seven days.

Other: Placebo

ALA group

ACTIVE COMPARATOR

ALA group: 40 septic patients will be given 1800 mg for seven days .

Dietary Supplement: Alpha-lipoic acid

Interventions

Placebo OTHER

placebo film-coated tablet orally or via a nasogastric tube for seven days .

Also known as: placebo film-coated tablet

Placebo Group

Alpha-lipoic acid DIETARY_SUPPLEMENT

Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days .

Also known as: Thiotex Forte® capsules

ALA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 31221283 BACKGROUND

• 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.

  PMID: 30754087 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Tarek Mostafa, Prof.

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into two groups (40 patients each): control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric/orogastric tube of ALA daily for seven days .

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 15, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)