Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT03930160
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LODS Role in Predicting 30-day Mortality Outcome in ICU
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LODS score discrimination ability', 'timeFrame': '30 days from admission', 'description': 'LODS score ability to discriminate patient outcomes based on variables of logistic organ dysfunction system scores: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.'}, {'measure': 'LODS score calibration', 'timeFrame': '30 days from admission', 'description': 'LODS score ability to predict patient outcomes based on variables of logistic organ dysfunction system scores: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.'}, {'measure': 'Correlation between LODS score variables with patient outcome', 'timeFrame': '30 days from admission', 'description': 'Correlation between patient outcomes with each LODS score variables: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.'}], 'secondaryOutcomes': [{'measure': 'Patient outcome', 'timeFrame': '30 days from admission', 'description': 'Patient outcome within 30 days of admission to intensive care unit (ICU): deceased or survived'}, {'measure': 'LODS neurologic variable score: Glasgow Coma Scale (GCS)', 'timeFrame': 'Day 1', 'description': 'The score for GCS variable cutoff:\n\n0 point for 14-15;\n\n1 point for 9-13; 3 points for 6-8; 5 points for 3-5.'}, {'measure': 'LODS cardiovascular variable score: Heart rate (HR) and/or systolic blood pressure (SBP)', 'timeFrame': 'Day 1', 'description': 'The score for HR (in bpm) and/or SBP (in mmHg) variable cutoff:\n\n0 point for HR 30-139 and SBP 90-239;\n\n1 point for SBP 70-89 or 240-269 or HR \\>=140; 3 points for SBP 40-69 or \\>=270; 5 points for HR \\<30 or SBP \\<40.'}, {'measure': 'LODS renal variable score: serum urea nitrogen (BUN) and/or creatinine and/or urine output (UO)', 'timeFrame': 'Day 1', 'description': 'The score for BUN (in mg/dL) and/or creatinine (in mg/dL) and/or UO (in litres/day) variable cutoff:\n\n0 point for BUN \\<17 AND creatinine \\<1.20 AND UO 0.75-9.99;\n\n1 point for BUN 17-\\<28 OR creatinine 1.20-1.59; 3 points for BUN 28-\\<56 AND creatinine \\<1.60 AND UO 0.5-0.74 or \\>=10; 5 points for BUN \\>=56 OR UO 0.5.'}, {'measure': 'LODS pulmonary variable score: Partial oxygen pressure (PaO2)/Fraction of inspired oxygen (FiO2) on Mechanical Ventilation (MV) or Continuous Positive Airway Pressure (CPAP)', 'timeFrame': 'Day 1', 'description': 'The score for PaO2/FiO2 (in mmHg/%) variable cutoff:\n\n0 point for no ventilation and no CPAP;\n\n1 point for \\>=150; 3 points for \\<150.'}, {'measure': 'LODS hematologic variable score: white blood cell (WBC) count and/or platelet count', 'timeFrame': 'Day 1', 'description': 'The score for WBC (in x10\\^3/L) and/or platelet count in (x10\\^3/L) variable cutoff:\n\n0 point for WBC 2.5-49.9 and platelet \\>=50;\n\n1 point for WBC 1.0-2.4 or \\>=50.0 OR platelet \\<50; 3 points for WBC \\<1.0'}, {'measure': 'LODS hepatic function variable score: Serum Bilirubin and/or Prothrombin time (PT)', 'timeFrame': 'Day 1', 'description': 'The score for serum bilirubin (in mg/dL) and/or PT (in % of standard) variable cutoff:\n\n0 point for bilirubin \\<2.0 and PT \\>=25;\n\n1 point for bilirubin \\>=2.0 OR PT\\<25% or \\>3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care unit', 'Logistic Organ Dysfunction System', '30-day Mortality', 'Sepsis', 'Mortality prediction'], 'conditions': ['Mortality']}, 'referencesModule': {'references': [{'pmid': '25159474', 'type': 'BACKGROUND', 'citation': 'Power GS, Harrison DA. 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Evaluation of the PaO2/FiO2 ratio after cardiac surgery as a predictor of outcome during hospital stay. BMC Anesthesiol. 2014 Sep 26;14:83. doi: 10.1186/1471-2253-14-83.'}, {'pmid': '25818272', 'type': 'BACKGROUND', 'citation': 'Villar J, Blanco J, del Campo R, Andaluz-Ojeda D, Diaz-Dominguez FJ, Muriel A, Corcoles V, Suarez-Sipmann F, Tarancon C, Gonzalez-Higueras E, Lopez J, Blanch L, Perez-Mendez L, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification & Therapies for ARDS (SIESTA) Network. Assessment of PaO(2)/FiO(2) for stratification of patients with moderate and severe acute respiratory distress syndrome. BMJ Open. 2015 Mar 27;5(3):e006812. doi: 10.1136/bmjopen-2014-006812.'}, {'pmid': '27074175', 'type': 'BACKGROUND', 'citation': 'Fialkow L, Farenzena M, Wawrzeniak IC, Brauner JS, Vieira SR, Vigo A, Bozzetti MC. Mechanical ventilation in patients in the intensive care unit of a general university hospital in southern Brazil: an epidemiological study. Clinics (Sao Paulo). 2016 Mar;71(3):144-51. doi: 10.6061/clinics/2016(03)05.'}]}, 'descriptionModule': {'briefSummary': 'LODS score for deceased ICU patients within 30 days is higher than survived ICU patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'intensive care unit patients medical records', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient (age 18 years and above) admitted to ICU\n\nExclusion Criteria:\n\n* patients admitted to ICU due to burn injury, coronary artery disease, post cardiac surgery\n* patients with incomplete required information for LODS score\n* patients deceased or discharged less than 24 hours of admission'}, 'identificationModule': {'nctId': 'NCT03930160', 'briefTitle': 'LODS Role in Predicting 30-day Mortality Outcome in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Logistic Organ Dysfunction System Role in Predicting 30-day Mortality Outcome in Intensive Care Unit of dr. Cipto Mangunkusumo General Hospital Patients', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mortality outcome', 'interventionNames': ['Other: Logistic Organ Dysfunction System Score']}], 'interventions': [{'name': 'Logistic Organ Dysfunction System Score', 'type': 'OTHER', 'otherNames': ['LODS'], 'description': 'Variables of logistic organ dysfunction system score, including: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.', 'armGroupLabels': ['Mortality outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Rumah Sakit Cipto Mangunkusumo', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Anesthesiologist Consultant', 'investigatorFullName': 'Dita Aditianingsih', 'investigatorAffiliation': 'Indonesia University'}}}}