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Alpha-Lipoic Acid in Patients With Sepsis

Primary Purpose

Sepsis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Alpha-Lipoic Acid
Sepsis Supportive Care
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Alpha Lipoic Acid, MCP-1, Mortality, Vasopressors, Efficacy, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years or older Patients able to receive oral or enteral medication 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: 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. Patients on mechanical ventilation at baseline. Pregnant women Patients already receiving ALA supplementation before ICU admission

Sites / Locations

  • Ain Shams University Specialized HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alpha-Lipoic Acid Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Mortality
The patient will be followed-up for mortality rate during hospital stay and up to 28 days.

Secondary Outcome Measures

Plasma MCP-1
Monocyte chemoattractant protein-1 (MCP-1) will be assessed in each patient as an inflammatory marker.
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.
Length of ICU stay
The total duration of ICU stay will be estimated for each patient.
Length of hospital stay
The total duration of hospital stay will be estimated for each patient.
Need for Mechanical Ventilation
Number of patients requiring mechanical ventilation will be recorded along with the duration of ventilation
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
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).

Full Information

First Posted
March 19, 2023
Last Updated
March 30, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05808946
Brief Title
Alpha-Lipoic Acid in Patients With Sepsis
Official Title
The Effect of Alpha-Lipoic Acid on the Clinical Outcome of Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Alpha Lipoic Acid, MCP-1, Mortality, Vasopressors, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alpha-Lipoic Acid Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Alpha-Lipoic Acid
Other Intervention Name(s)
Thioctic Acid
Intervention Description
1200 mg of ALA daily (given as two 600 mg capsules once daily)
Intervention Type
Drug
Intervention Name(s)
Sepsis Supportive Care
Other Intervention Name(s)
Sepsis Management
Intervention Description
Appropriate IV fluid, Appropriate antibiotic, Vasopressors if needed, Mechanical ventilation if needed
Primary Outcome Measure Information:
Title
Mortality
Description
The patient will be followed-up for mortality rate during hospital stay and up to 28 days.
Time Frame
28 days since patient enrollment in the study
Secondary Outcome Measure Information:
Title
Plasma MCP-1
Description
Monocyte chemoattractant protein-1 (MCP-1) will be assessed in each patient as an inflammatory marker.
Time Frame
Plasma samples will be collected on days 1, 3 and 7 for each patient enrolled
Title
SOFA score
Description
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.
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.
Title
Length of ICU stay
Description
The total duration of ICU stay will be estimated for each patient.
Time Frame
28 days
Title
Length of hospital stay
Description
The total duration of hospital stay will be estimated for each patient.
Time Frame
28 days
Title
Need for Mechanical Ventilation
Description
Number of patients requiring mechanical ventilation will be recorded along with the duration of ventilation
Time Frame
28 days
Title
Need for Vasopressors
Description
Number of patients requiring vasopressors as norepinephrine or dopamine will be recorded along with the dose and the duration of vasopressor administration
Time Frame
28 days
Title
Adverse Effects of Alpha-Lipoic Acid
Description
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).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years or older Patients able to receive oral or enteral medication 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: 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. Patients on mechanical ventilation at baseline. Pregnant women Patients already receiving ALA supplementation before ICU admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lujayna M AbdElAziz
Phone
+20 1066471293
Email
lujayna.mostafa20@pharma.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lujayna M AbdelAziz
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Specialized Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Alpha-Lipoic Acid in Patients With Sepsis

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