deltatrials
Completed INTERVENTIONAL NCT06661993

Alpha-lipoic Acid in Critically Ill Patients With Sepsis

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

Sponsor: Damanhour University

Conditions Sepsis
Updated 3 times since 2024 Last updated: Apr 17, 2026 Started: Oct 15, 2024 Primary completion: Oct 28, 2025 Completion: Oct 28, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Sepsis, this trial is completed. The trial is conducted by Damanhour University and has accumulated 3 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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).

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).

Status Flow

~Nov 2024 – ~Jan 2026 · 14 months · monthly snapshotRecruiting~Jan 2026 – ~Apr 2026 · 4 months · monthly snapshotCompletedApr 23, 2026 – present · 4 months · daily APICompleted

Change History

3 versions recorded
  1. Apr 23, 2026 — Present [daily]

    Completed

    Phase: NANone

  2. Jan 2026 — Apr 2026 [monthly]

    Completed NA

    Status: RecruitingCompleted

  3. Nov 2024 — Jan 2026 [monthly]

    Recruiting NA

    First recorded

Oct 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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 .

Contact Information

Sponsor contact:
  • Damanhour University
  • Tanta University
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations