Alpha-lipoic Acid in Critically Ill Patients With Sepsis

April 17, 2026 updated by: Rehab Werida, Damanhour University

Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
control group: 40 septic patients will receive placebo daily for seven days.
Other: Placebo
placebo film-coated tablet orally or via a nasogastric tube for seven days .
Other Names:
  • placebo film-coated tablet
Active Comparator: ALA group
ALA group: 40 septic patients will be given 1800 mg for seven days .
Dietary supplement: Alpha-lipoic acid
Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days .
Other Names:
  • Thiotex Forte® capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Organ Failure Assessment (SOFA) Score
Time Frame: 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.
1 week
CRP (mg/L)
Time Frame: 1 Week
Inflammatory marker
1 Week
Syndecan 1 (ng/mL)
Time Frame: 1 Week
glycocalyx degradation marker
1 Week
IL-6 (pg/mL)
Time Frame: 1 Week
Inflammatory marker
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU and hospital stay
Time Frame: 28 days
Duration (days)
28 days
ventilator-free days within 28 days
Time Frame: 28 days
Duration (days)
28 days
the duration of vasopressor therapy
Time Frame: 1 Week
Duration (days)
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • Study Chair: Tarek Mostafa, Prof., Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

October 28, 2025

Study Completion (Actual)

October 28, 2025

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • alpha-lipoic acid in sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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