NCT05808946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 sepsis

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

March 19, 2023

Last Update Submit

March 30, 2023

Conditions

Sepsis

Keywords

Alpha Lipoic AcidMCP-1MortalityVasopressorsEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Plasma MCP-1

    Plasma samples will be collected on days 1, 3 and 7 for each patient enrolled

  • SOFA score

    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

    28 days

  • Length of hospital stay

    28 days

  • Need for Mechanical Ventilation

    28 days

  • +2 more secondary outcomes

Study Arms (2)

Alpha-Lipoic Acid Group

EXPERIMENTAL
Drug: Alpha-Lipoic AcidDrug: Sepsis Supportive Care

Control Group

ACTIVE COMPARATOR
Drug: Sepsis Supportive Care

Interventions

Alpha-Lipoic AcidDRUG

1200 mg of ALA daily (given as two 600 mg capsules once daily)

Also known as: Thioctic Acid
Alpha-Lipoic Acid Group
Sepsis Supportive CareDRUG

Appropriate IV fluid, Appropriate antibiotic, Vasopressors if needed, Mechanical ventilation if needed

Also known as: Sepsis Management
Alpha-Lipoic Acid GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Specialized Hospital

Cairo, Egypt

RECRUITING

Related Publications (19)

  • Soltani R, Alikiaie B, Shafiee F, Amiri H, Mousavi S. Coenzyme Q10 improves the survival and reduces inflammatory markers in septic patients. Bratisl Lek Listy. 2020;121(2):154-158. doi: 10.4149/BLL_2020_022.

    PMID: 32115970BACKGROUND

  • Zhu T, Liao X, Feng T, Wu Q, Zhang J, Cao X, Li H. Plasma Monocyte Chemoattractant Protein 1 as a Predictive Marker for Sepsis Prognosis: A Prospective Cohort Study. Tohoku J Exp Med. 2017 Feb;241(2):139-147. doi: 10.1620/tjem.241.139.

    PMID: 28202856BACKGROUND

  • Lowes DA, Webster NR, Murphy MP, Galley HF. Antioxidants that protect mitochondria reduce interleukin-6 and oxidative stress, improve mitochondrial function, and reduce biochemical markers of organ dysfunction in a rat model of acute sepsis. Br J Anaesth. 2013 Mar;110(3):472-80. doi: 10.1093/bja/aes577. Epub 2013 Feb 4.

    PMID: 23381720BACKGROUND

  • Salehi B, Berkay Yilmaz Y, Antika G, Boyunegmez Tumer T, Fawzi Mahomoodally M, Lobine D, Akram M, Riaz M, Capanoglu E, Sharopov F, Martins N, Cho WC, Sharifi-Rad J. Insights on the Use of alpha-Lipoic Acid for Therapeutic Purposes. Biomolecules. 2019 Aug 9;9(8):356. doi: 10.3390/biom9080356.

    PMID: 31405030BACKGROUND

  • Park S, Karunakaran U, Jeoung NH, Jeon JH, Lee IK. Physiological effect and therapeutic application of alpha lipoic acid. Curr Med Chem. 2014;21(32):3636-45. doi: 10.2174/0929867321666140706141806.

    PMID: 25005184BACKGROUND

  • Dewi Perwito Sari, I.S.a.J.K., THE MECHANISM OF ALA ON REDUCING THE MDA LEVEL AND MCP-1 EXPRESSION IN ENDOTHELIAL DYSFUNCTION OF HYPERCHOLESTEROLEMIA RAT MODEL. Folia Medica Indonesiana, 2016. 52.

    BACKGROUND

  • Rius-Perez S, Torres-Cuevas I, Millan I, Ortega AL, Perez S. PGC-1alpha, Inflammation, and Oxidative Stress: An Integrative View in Metabolism. Oxid Med Cell Longev. 2020 Mar 9;2020:1452696. doi: 10.1155/2020/1452696. eCollection 2020.

    PMID: 32215168BACKGROUND

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

  • Tibullo D, Li Volti G, Giallongo C, Grasso S, Tomassoni D, Anfuso CD, Lupo G, Amenta F, Avola R, Bramanti V. Biochemical and clinical relevance of alpha lipoic acid: antioxidant and anti-inflammatory activity, molecular pathways and therapeutic potential. Inflamm Res. 2017 Nov;66(11):947-959. doi: 10.1007/s00011-017-1079-6. Epub 2017 Jul 4.

    PMID: 28676917RESULT

  • Mendoza-Nunez VM, Garcia-Martinez BI, Rosado-Perez J, Santiago-Osorio E, Pedraza-Chaverri J, Hernandez-Abad VJ. The Effect of 600 mg Alpha-lipoic Acid Supplementation on Oxidative Stress, Inflammation, and RAGE in Older Adults with Type 2 Diabetes Mellitus. Oxid Med Cell Longev. 2019 Jun 12;2019:3276958. doi: 10.1155/2019/3276958. eCollection 2019.

    PMID: 31285784RESULT

  • Gomes MB, Negrato CA. Alpha-lipoic acid as a pleiotropic compound with potential therapeutic use in diabetes and other chronic diseases. Diabetol Metab Syndr. 2014 Jul 28;6(1):80. doi: 10.1186/1758-5996-6-80. eCollection 2014.

    PMID: 25104975RESULT

  • Dworacka M, Iskakova S, Krzyzagorska E, Wesolowska A, Kurmambayev Y, Dworacki G. Alpha-lipoic acid modifies circulating angiogenic factors in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2015 Feb;107(2):273-9. doi: 10.1016/j.diabres.2014.11.005. Epub 2014 Dec 3.

    PMID: 25511715RESULT

  • Jia J, Gong X, Zhao Y, Yang Z, Ji K, Luan T, Zang B, Li G. Autophagy Enhancing Contributes to the Organ Protective Effect of Alpha-Lipoic Acid in Septic Rats. Front Immunol. 2019 Jul 2;10:1491. doi: 10.3389/fimmu.2019.01491. eCollection 2019.

    PMID: 31333648RESULT

  • Petronilho F, Florentino D, Danielski LG, Vieira LC, Martins MM, Vieira A, Bonfante S, Goldim MP, Vuolo F. Alpha-Lipoic Acid Attenuates Oxidative Damage in Organs After Sepsis. Inflammation. 2016 Feb;39(1):357-365. doi: 10.1007/s10753-015-0256-4.

    PMID: 26431839RESULT

  • Hiller S, DeKroon R, Xu L, Robinette J, Winnik W, Alzate O, Simington S, Maeda N, Yi X. alpha-Lipoic acid protects mitochondrial enzymes and attenuates lipopolysaccharide-induced hypothermia in mice. Free Radic Biol Med. 2014 Jun;71:362-367. doi: 10.1016/j.freeradbiomed.2014.03.022. Epub 2014 Mar 24.

    PMID: 24675228RESULT

  • Della Giustina A, Goldim MP, Danielski LG, Florentino D, Mathias K, Garbossa L, Oliveira Junior AN, Fileti ME, Zarbato GF, da Rosa N, Martins Laurentino AO, Fortunato JJ, Mina F, Bellettini-Santos T, Budni J, Barichello T, Dal-Pizzol F, Petronilho F. Alpha-lipoic acid attenuates acute neuroinflammation and long-term cognitive impairment after polymicrobial sepsis. Neurochem Int. 2017 Sep;108:436-447. doi: 10.1016/j.neuint.2017.06.003. Epub 2017 Jun 10.

    PMID: 28606823RESULT

  • Jiang S, Zhu W, Li C, Zhang X, Lu T, Ding Z, Cao K, Liu L. alpha-Lipoic acid attenuates LPS-induced cardiac dysfunction through a PI3K/Akt-dependent mechanism. Int Immunopharmacol. 2013 May;16(1):100-7. doi: 10.1016/j.intimp.2013.03.024. Epub 2013 Apr 3.

    PMID: 23562296RESULT

  • Koh EH, Lee WJ, Lee SA, Kim EH, Cho EH, Jeong E, Kim DW, Kim MS, Park JY, Park KG, Lee HJ, Lee IK, Lim S, Jang HC, Lee KH, Lee KU. Effects of alpha-lipoic Acid on body weight in obese subjects. Am J Med. 2011 Jan;124(1):85.e1-8. doi: 10.1016/j.amjmed.2010.08.005.

    PMID: 21187189RESULT

  • Kim BJ, Hunter A, Brucker AJ, Hahn P, Gehrs K, Patel A, Edwards AO, Li Y, Khurana RN, Nissim I, Daniel E, Grunwald J, Ying GS, Pistilli M, Maguire MG, Dunaief JL. Orally Administered Alpha Lipoic Acid as a Treatment for Geographic Atrophy: A Randomized Clinical Trial. Ophthalmol Retina. 2020 Sep;4(9):889-898. doi: 10.1016/j.oret.2020.03.019. Epub 2020 Apr 2.

    PMID: 32418846RESULT

MeSH Terms

Conditions

Sepsis

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Lujayna M AbdelAziz

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lujayna M AbdElAziz

CONTACT

+20 1066471293lujayna.mostafa20@pharma.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 12, 2023

Study Start

March 10, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)