Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06661993
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alpha-lipoic Acid in Critically Ill Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into two groups (40 patients each): control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': '1 week', 'description': 'The SOFA score is a composite score based on the degree of dysfunction in six organ systems-respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. Each organ dysfunction scores from 0 to 4, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention. The higher the SOFA score, the higher the likely mortality.'}, {'measure': 'ICU and hospital stay', 'timeFrame': '1 month', 'description': 'Duration (days)'}], 'secondaryOutcomes': [{'measure': 'Syndecan 1 (ug/dl)', 'timeFrame': '1 Week', 'description': 'glycocalyx degradation marker'}, {'measure': 'CRP (ug/dl)', 'timeFrame': '1 Week', 'description': 'Inflammatory marker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '31221283', 'type': 'BACKGROUND', 'citation': 'Rahimlou M, Asadi M, Banaei Jahromi N, Mansoori A. Alpha-lipoic acid (ALA) supplementation effect on glycemic and inflammatory biomarkers: A Systematic Review and meta- analysis. Clin Nutr ESPEN. 2019 Aug;32:16-28. doi: 10.1016/j.clnesp.2019.03.015. Epub 2019 May 2.'}, {'pmid': '30754087', 'type': 'BACKGROUND', 'citation': 'Thompson K, Venkatesh B, Finfer S. Sepsis and septic shock: current approaches to management. Intern Med J. 2019 Feb;49(2):160-170. doi: 10.1111/imj.14199.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the of effect of alpha-lipoic acid in critically ill septic patients. 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .', 'detailedDescription': '1. Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhour University \\& Ethics committee of Damanhur National Medical National Institute.\n2. All participants or their relatives should agree to take part in this clinical study and will provide informed consent.\n3. 80 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .\n4. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.\n5. Results, conclusion, discussion and recommendations will be given. Outcomes 1. The primary outcome ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) 2. The secondary outcome are as follows: A. 28-day all-cause mortality B. change in inflammatory markers such as CRP , IL6, and TNF Alpha and may be measured glycocalyx degradation markers such as syndecan 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be diagnosed with sepsis or develop sepsis during their ICU length of stay\n* Age 18 year and older\n* Patient able to receive oral or enteral medication\n\nExclusion Criteria:\n\n* Patients who will be diagnosed with septic shock\n* Female patients who are pregnant or lactating.\n* Participation in another clinical trial.\n* Current treatment with other medications that have antioxidant effects, such as vitamin C and vitamin E.\n* Allergy to LA or similar active agents (e.g., vitamin B), or previous intolerance to the recommended dose of LA'}, 'identificationModule': {'nctId': 'NCT06661993', 'briefTitle': 'Alpha-lipoic Acid in Critically Ill Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Effect of Alpha-lipoic Acid in Critically Ill Patients With Sepsis', 'orgStudyIdInfo': {'id': 'alpha-lipoic acid in sepsis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'control group: 40 septic patients will receive placebo daily for seven days.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ALA group', 'description': 'ALA group: 40 septic patients will be given 1800 mg orally or via a nasogastric tube daily for seven days .', 'interventionNames': ['Dietary Supplement: Alpha-lipoic acid']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo film-coated tablet'], 'description': 'placebo film-coated tablet orally or via a nasogastric tube for seven days .', 'armGroupLabels': ['Placebo Group']}, {'name': 'Alpha-lipoic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Thiotacid 1800 mg'], 'description': 'Alpha-lipoic acid 1800 mg orally or via a nasogastric tube for seven days .', 'armGroupLabels': ['ALA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Damanhūr', 'state': 'Elbehairah', 'country': 'Egypt', 'facility': 'Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Tarek Mostafa, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rehab Werida', 'investigatorAffiliation': 'Damanhour University'}}}}