Alpha-Lipoic Acid in Patients With Sepsis

March 30, 2023 updated by: Lujayna AbdelAziz, Ain Shams University

The Effect of Alpha-Lipoic Acid on the Clinical Outcome of Patients With Sepsis

Alpha-lipoic acid (ALA) is a powerful antioxidant that can help reduce the harmful effects of free radicals in the body. When the body is fighting sepsis, the immune response generates a lot of free radicals that can damage cells and tissues. ALA can neutralize these free radicals, reducing oxidative stress and preventing damage to cells and tissues.

ALA also has anti-inflammatory properties, meaning it can reduce inflammation in the body. Inflammation is a key feature of sepsis, and it can cause damage to organs and tissues. By reducing inflammation, ALA can help prevent damage to organs and tissues, reducing the risk of sepsis complications such as organ failure.

The objective of this research is to investigate the impact of ALA on individuals who have sepsis. The study will involve dividing the participants into two groups: a control group and an ALA group. The control group will receive the standard supportive care for sepsis management. Meanwhile, the ALA group will receive 1200 mg of ALA daily in addition to the standard care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is considered a leading cause of death in hospitals and intensive care units (ICU) due to the body's excessive response to the invading pathogen, resulting in severe inflammation and oxidative stress. As a result, it is postulated that administering anti-inflammatory and antioxidant agents may have potential benefits on the clinical outcomes of patients with sepsis. Alpha-lipoic acid, a nutraceutical with both potent anti-inflammatory and antioxidant properties, could be a potential treatment option. Several animal models showed positive results when using ALA in septic rats. Hence, it might be a potential candidate for improving the clinical outcome in septic patients. Thus, the aim of this study is to evaluate the efficacy and safety of alpha-lipoic acid when administered at a dose of 1200 mg/day in septic patients.

This trial is a prospective randomized-controlled open label trial where a total number of 60 patients will be enrolled in the study. They will be randomized using simple randomization into the control group and the treatment group with a ratio of 1 to 1 (30 patients in each group). The control group will receive the standard supportive care of sepsis management. Supportive care typically involves a combination of interventions to stabilize the patient's condition and manage their symptoms such as administration of intravenous fluids (e.g.: normal saline) and appropriate antibiotics. Additionally, oxygen therapy, mechanical ventilation, and vasopressors (e.g.: norepinephrine or dobutamine) may be provided on an as-needed basis to support breathing and maintain blood pressure. Meanwhile, the ALA group will be given 1200 mg of ALA daily in addition to the standard care.

The efficacy of ALA will be assessed by tracking the mortality rates of enrolled patients during their hospital stay and 28 days after, as well as the duration of their ICU and hospital stay. The Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, C-reactive protein (CRP), Total Leukocytic Count (TLC), and plasma monocyte chemoattractant protein 1 (MCP-1) will also be measured at baseline and regularly during the study to evaluate ALA's impact on sepsis. Also, the need for mechanical ventilation and vasopressors will be recorded as an indicator of ALA's efficacy. The safety of ALA will be determined by monitoring the patients for any adverse effects that may occur due to the drug such as nausea or itching.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Specialized Hospital

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:

  1. Patients 18 years or older
  2. Patients able to receive oral or enteral medication
  3. Patients with confirmed diagnosis of sepsis according to Sepsis-3 definition; documented or suspected infection associated with organ dysfunction identified by acute change in total SOFA score of 2 points or more.

Exclusion Criteria:

  1. Patients with septic shock defined as patients with sepsis who has persistent hypotension that necessitates the use of vasopressors to maintain MAP greater than or equal to 65mmHg and a blood lactate level greater than 2 mmol/L (18 mg/dL) despite absence of hypovolemia.
  2. Patients on mechanical ventilation at baseline.
  3. Pregnant women
  4. Patients already receiving ALA supplementation before ICU admission

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Drug: Sepsis Supportive Care
Appropriate IV fluid, Appropriate antibiotic, Vasopressors if needed, Mechanical ventilation if needed
Other Names:
  • Sepsis Management
Experimental: Alpha-Lipoic Acid Group
Drug: Alpha-Lipoic Acid
1200 mg of ALA daily (given as two 600 mg capsules once daily)
Other Names:
  • Thioctic Acid
Drug: Sepsis Supportive Care
Appropriate IV fluid, Appropriate antibiotic, Vasopressors if needed, Mechanical ventilation if needed
Other Names:
  • Sepsis Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days since patient enrollment in the study
The patient will be followed-up for mortality rate during hospital stay and up to 28 days.
28 days since patient enrollment in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma MCP-1
Time Frame: Plasma samples will be collected on days 1, 3 and 7 for each patient enrolled
Monocyte chemoattractant protein-1 (MCP-1) will be assessed in each patient as an inflammatory marker.
Plasma samples will be collected on days 1, 3 and 7 for each patient enrolled
SOFA score
Time Frame: Assessed on day 1, 3 and 7 and then every 3 days till patient is discharged or death occurs, up to maximum 28 days.

A scoring system used to measure the extent of organ dysfunction/failure in critically ill patients. The score is calculated based on six different parameters: respiratory (PaO2/FiO2 ratio), cardiovascular (mean arterial pressure (MAP)), hepatic (serum bilirubin level), coagulation (platelet count), renal (serum creatinine level and urine output), and neurological (Glasgow Coma Scale).

This makes the SOFA score a composite outcome.
Assessed on day 1, 3 and 7 and then every 3 days till patient is discharged or death occurs, up to maximum 28 days.
Length of ICU stay
Time Frame: 28 days
The total duration of ICU stay will be estimated for each patient.
28 days
Length of hospital stay
Time Frame: 28 days
The total duration of hospital stay will be estimated for each patient.
28 days
Need for Mechanical Ventilation
Time Frame: 28 days
Number of patients requiring mechanical ventilation will be recorded along with the duration of ventilation
28 days
Need for Vasopressors
Time Frame: 28 days
Number of patients requiring vasopressors as norepinephrine or dopamine will be recorded along with the dose and the duration of vasopressor administration
28 days
Adverse Effects of Alpha-Lipoic Acid
Time Frame: 28 days
All adverse effects experienced by the participants will be recorded in both arms. Expected side effects include gastrointestinal side effects (e.g.: nausea and vomiting) and hypersensitivity of the skin (e.g.: urticaria and itching sensation).
28 days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Lujayna M AbdelAziz, Ain Shams 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)

March 10, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUC-FP-ASURHDIRB2020110301158

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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