Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05825118
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
N\L Ratio Versus L\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of 28 day mortality.', 'timeFrame': '28 days', 'description': 'Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge).'}], 'secondaryOutcomes': [{'measure': 'Extent of organ dysfunction in patients with sepsis and septic shock assessed by SOFA score', 'timeFrame': '0 hours, 6 hours, 24 hours of admission to icu', 'description': 'SOFA score for assessment of organ dysfunction in 0 hours, 6 hours, 24 hours of admission to icu.'}]}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '33451890', 'type': 'BACKGROUND', 'citation': 'Fortini A, Faraone A, Meini S, Bettucchi M, Longo B, Valoriani B, Forni S; Italian Federation of Hospital Internists (FADOI) - Sepsis Collaboration Group of the Tuscany Region. Validity of "Sepsis-3" criteria in identifying patients with community-onset sepsis in Internal Medicine wards; a prospective, multicenter study. Eur J Intern Med. 2021 Mar;85:92-97. doi: 10.1016/j.ejim.2020.12.025. Epub 2021 Jan 12.'}, {'pmid': '23442987', 'type': 'BACKGROUND', 'citation': 'Gaieski DF, Edwards JM, Kallan MJ, Carr BG. Benchmarking the incidence and mortality of severe sepsis in the United States. Crit Care Med. 2013 May;41(5):1167-74. doi: 10.1097/CCM.0b013e31827c09f8.'}, {'pmid': '31611560', 'type': 'BACKGROUND', 'citation': 'Cao C, Yu M, Chai Y. Pathological alteration and therapeutic implications of sepsis-induced immune cell apoptosis. Cell Death Dis. 2019 Oct 14;10(10):782. doi: 10.1038/s41419-019-2015-1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare between neutrophil lymphocyte ratio and lactate albumin ratio as a predictor of morbidity and mortality in sepsis and septic shock patients.', 'detailedDescription': "Sepsis is a systemic inflammatory response syndrome caused by infection can lead to life threatening multi-organ dysfunction.\n\nSeptic shock causes circulatory and metabolic abnormalities, leading to increased mortality in hospitalized patients, especially in intensive care unit (ICU) patients.\n\nSepsis can affect the function and number of immune cells, including neutrophils, lymphocytes and monocytes.\n\nNeutrophils play crucial roles in the innate cellular immune system. Early higher neutrophil counts correlated with increased sepsis severity.\n\nIn sepsis, lymphocytes decrease owing to the apoptosis mediated by innate response.\n\nReversily, number of neutrophils dramatically increase reflecting degree of inflammation.\n\nThe neutrophil-to-lymphocyte ratio (NLR) is a novel inflammatory biomarker that can be obtained through blood routine tests, it is cost- effective and widely available, and it is beneficial to the early recognition of poor prognosis in septic patients.\n\nAlbumin is a molecule that is the most abundant protein in plasma. For a variety of physiological mechanisms, albumin has a variety of function, including serving as a major buffer, extracellular antioxidant, immune modulator, antidote and transporter in plasma.\n\nIncreased capillary leakage of albumin is one of the features of SIRS. This means that lower albumin levels correlate with severe systemic inflammation and organ failure.\n\nHypoxia and tissue hypo perfusion seen in sepsis play a key role on the development of multi-organ failure in septic patients.\n\nLactic acidosis is one of the best indicators of the insufficient perfusion or development of anaerobic metabolism during septic shock.\n\nThe inability of liver to metabolize lactate as a result of the deterioration of liver perfusion also increases lactate levels.\n\nThe measurement of blood lactate levels used to determine tissue hypoxia is rapid, inexpensive and easy.\n\nBecause lactate and albumin levels progress differently as the development of sepsis proceeds, a ratio between the two rather than analyzing lactate and albumin alone may be a new and perhaps better indicator for the patient's prognosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient of both sex with age between 18-60 years old admitted to SICU suffering from sepsis and septic shock will be enrolled in the study after fulfillment of the following inclusion and exclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age from 18 to 60 years old.\n* Patients with suspected infection who fulfilled at least two of three quick sepsis - related organ failure assessment (QSOFA) criteria\n* Patients with Organ dysfunction can be confirmed by acute change in SOFA score variables \\>2 points consequent to infection.\n* Sepsis with persisting hypotension requiring vasopressors to maintain MAP \\> 65 mm Hg and having a serum lactate level \\> 2mmol/L despite adequate volume of resuscitation.\n\nExclusion criteria\n\n* No informed consent.\n* Malignancy and chemotherapy during the previous 90 days.\n* History of steroid therapy within 3 months before admission.\n* Patients with either established hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burn.'}, 'identificationModule': {'nctId': 'NCT05825118', 'briefTitle': 'N\\L Ratio Versus L\\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio as a Predictor of Morbidity and Mortality in Patients With Sepsis and Septic Shock', 'orgStudyIdInfo': {'id': 'N\\L and L\\A in sepsis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood will be drawn from peripheral vein, arterial or a central catheter for evaluation of whole blood count, serum lactate and serum albumin.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Walaa A Elbialy, resident', 'role': 'CONTACT', 'email': 'walaa161071_pg@med.tanta.edu.egy', 'phone': '+201095519412'}], 'facility': 'Tanta U', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Walaa A Elbialy, resident', 'role': 'CONTACT', 'email': 'walaa161071_pg@med.tanta.edu.eg', 'phone': '+201095519412'}], 'overallOfficials': [{'name': 'Sabry M Ameen, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}, {'name': 'Ahmed A abdelhafez, assist. pro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}, {'name': 'Alaa M Abohagar, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Walaa Adel Abdelghafar Elbialy', 'investigatorAffiliation': 'Tanta University'}}}}