Alpha-Lipoic Acid in Patients With Sepsis

Sepsis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sepsis
• Toxemia

• NCT number: NCT05808946
• Study type: Interventional
• Source: Ain Shams University
• Contact: Lujayna M AbdElAziz
• Phone: +20 1066471293
• Email: lujayna.mostafa20@pharma.asu.edu.eg
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 10, 2023
• Completion date: October 2024