Alpha-lipoic Acid in Critically Ill Patients With Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-10-28

Brief Summary

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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 .

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Detailed Description

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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. 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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 tube of ALA daily for seven days .

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

ALA group

ALA group: 40 septic patients will be given 1800 mg orally or via a nasogastric tube daily for seven days .

Group Type ACTIVE_COMPARATOR

Alpha-lipoic acid

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

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

Intervention Type OTHER

Alpha-lipoic acid

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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placebo film-coated tablet Thiotacid 1800 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No