Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-21 @ 4:17 PM
Study NCT ID:
NCT02779933
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Risk Factors for Hospital-acquired Pneumonia (HAP) in Intensive Care Unit (ICU) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}], 'ancestors': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'endotracheal aspirate'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality (non modifiable HAP risk factor)', 'timeFrame': '30 days', 'description': 'Yes/No assessment'}], 'secondaryOutcomes': [{'measure': 'Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Assessment if mechanical ventilation was provided, or for how long'}, {'measure': 'Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Assessment if hospital stay was present, or for how long'}, {'measure': 'Repeated transport of the patient from the ICU (non modifiable HAP risk factor)', 'timeFrame': '30 days', 'description': 'Assessment if repeated transports were present or not'}, {'measure': 'Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Assessment if physiotherapy was provided or not'}, {'measure': 'Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Bronchoscopy before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Sedation administration before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days'}, {'measure': 'Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Diabetes mellitus before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Ischemic heart disease before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Hypertension before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}, {'measure': 'Multi-organ failure before onset of HAP (modifiable HAP risk factor)', 'timeFrame': '7 days', 'description': 'Yes/No assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hospital-acquired Pneumonia', 'Epidemiology', 'Risk Factors'], 'conditions': ['Ventilator-Associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '28461706', 'type': 'DERIVED', 'citation': 'Uvizl R, Kolar M, Herkel T, Vobrova M, Langova K. Possibilities for modifying risk factors for the development of hospital-acquired pneumonia in intensive care patients: results of a retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Sep;161(3):303-309. doi: 10.5507/bp.2017.019. Epub 2017 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'A retrospective, observational study compiled data from all consecutively admitted patients older than 18 years at ICU University Hospital in Olomouc in the period from 1 January 2011 to 31 December 2015 who fulfilled the criteria of HAP. The aim was to determine the severity of the specific risk factors of early and late HAP. Risk factors were divided into factors from the patient and from the hospitalization. Furthermore, an assessment of their relationship to mortality.', 'detailedDescription': 'The primary outcome was to evaluate the relationship between risk factors and the development of early/late onset HAP. Another outcome was assessed to evaluate the relation of risk factors early/late onset HAP and mortality. The crucial time for evaluating the presence of risk factors was their presence from hospital admission to the moment of fulfilling the criteria for pneumonia. Risk factors were divided into two groups, on factors of the patient (uncontrollable) and by the hospitalization (controllable). Factors of the patient were: gender (male/female), age at enrollment (years), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, multi-organ failure presence (MOF), hypertension, ischemic heart disease (IHD) chronic renal insufficiency (CRI), continual use of renal replacement therapy (CRRT), acute renal insufficiency (ARI), diabetes mellitus (DM), Chronical Obstructive Pulmonary Disease (COPD), immunosuppression or leukopenia \\<1.5x109/l, impaired consciousness with Glasgow coma scale (GCS) \\<8 tracheotomy, head trauma/neurosurgery, abdominal surgery-thoracotomy. Side factors hospitalization were: aspiration into the lungs, urgent intubation, reintubated, sedation, bronchoscopy, nasogastric intubation, enteral feeding continuously/intermittently intolerance of enteral nutrition, physiotherapy, repeated transport of the patient from the ICU, length of hospital stay, length of mechanical ventilation, 30-day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included patients hospitalized in the ICU Department of Anesthesiology and Intensive Care Medicine, UH Olomouc. On inclusion did not affect the method of ensuring lower airways (invasive/non-invasive) or results (positivity/negativity) taken microbiological samples from the lower airways (endobronchial aspirate or bronchoalveolar lavage) as approximately one third of samples can be microbiologically negative even when overt bronchopneumonia. Patient cohort consisted of all patients older than 18 years who met the clinical criteria and HAP were consecutively admitted to the ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital-Acquired Pneumonia\n* Intensive Care patient\n* X-ray signs of pneumonia\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Negative culture findings in the airways\n* Low quantity of culture findings'}, 'identificationModule': {'nctId': 'NCT02779933', 'briefTitle': 'Epidemiology of Risk Factors for Hospital-acquired Pneumonia (HAP) in Intensive Care Unit (ICU) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Olomouc'}, 'officialTitle': 'Epidemiology of Risk Factors for Hospital-acquired Pneumonia in ICU Patients', 'orgStudyIdInfo': {'id': '63/16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epidemiology od HAP', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Radovan Uvizl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Olomouc, Czech Republic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Collecting data from individual patients medical documentation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUDr., Ph.D.', 'investigatorFullName': 'Radovan Uvizl', 'investigatorAffiliation': 'University Hospital Olomouc'}}}}