Sepsis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Specialized Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | 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 | Plasma MCP-1 | 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 | |
Secondary | SOFA score | 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. | |
Secondary | Length of ICU stay | The total duration of ICU stay will be estimated for each patient. | 28 days | |
Secondary | Length of hospital stay | The total duration of hospital stay will be estimated for each patient. | 28 days | |
Secondary | Need for Mechanical Ventilation | Number of patients requiring mechanical ventilation will be recorded along with the duration of ventilation | 28 days | |
Secondary | Need for Vasopressors | Number of patients requiring vasopressors as norepinephrine or dopamine will be recorded along with the dose and the duration of vasopressor administration | 28 days | |
Secondary | Adverse Effects of Alpha-Lipoic Acid | 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 |
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