Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT04467892
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2020-06-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'C025429', 'term': 'methyl prednisolonate'}, {'id': 'D012122', 'term': 'Ventilators, Mechanical'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'patients with COPD respiratory failure, patients with congestive heart failure'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who had severe chest trauma with massive lung contusion and admitted to King Abdelaziz specialist hospital between January 2018 and February 2020 in the intensive care unit those who showed the following inclusion criteria of ARDS, respiratory failure due to severe lung contusion complicated by VAP enrolled in our study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-06-06', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients weaned from the ventilators', 'timeFrame': '2 weeks', 'description': 'followed by arterial oxygen saturation'}, {'measure': 'Number of patients discharge from ICU', 'timeFrame': '2 weeks', 'description': 'number of patients weaned and ready to be discharged from ICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'patients who had \\>3 on Murray score and \\>6 on CPIS allocated randomly in two groups 120 patients in each. Group A received 30 mg/kg methyl-prednisolone slowly intravenous in 250 mL normal saline every 8 hours for only 48 hours while group B received 1 mg/kg/day methyl-prednisolone divided to three doses given every 8 hours for two weeks. Duration of the study last 16 days, Morbidity considered if no improvement in any or all clinical parameters of both Murray and CPIS scores and failure of weaning of patients from the ventilator at the studied period.', 'detailedDescription': 'Adult patients aged \\>18\\<65 years, hypercapnia with PH \\<7.25, hypoxic index less than 200 (PaO2/FIO2), bilateral parenchymatous lung infiltration in the chest Xray. All selected patients received conventional ventilation with protective lung strategy for 3 days with Controlled mechanical ventilation mode (CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure (PEEP) adjusted to achieve target arterial oxygen saturation (SPO2) of \\>90%. Sedation and pain control done by both midazolam and fentanyl infusion to achieve Richmond Agitation- Sedation Scale (RASS) -2. Protective lung strategy applied and include, head elevation more than 45-degree, daily assessment for both analgesic and sedative dose, early naso-gastric feeding to prevent bacterial translocation and flooding of the blood with gram negative septicemia, usage of the minimal PEEP to maintain SPO2 \\>90%. Qualitative sputum culture was taken after 3 days from ventilation. After 3 days from the conventional ventilation only 240 patients enrolled in our study. Those who had a Murray score (for diagnosis of ARDS) of \\>3 and CPIS (clinical pulmonary infection score) (for diagnosis of VAP) \\> 6. All patients were randomly allocated in 2 groups 120 patients in each. All patients received intravenous antibiotics meropenem 1 gm slowly intravenous every 8 hours for the first 8 days then antibiotics was given according to sputum culture and antibiotics sensitivity. Group A received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days while group B included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. This study conducted for 16 days.\n\nVAP diagnosed in our study by CPIS 6 or more while severity of lung contusion assessed by Murray score 3 or more'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ventilator associated pneumonia patients\n\nExclusion Criteria:\n\n* post cardiac arrest'}, 'identificationModule': {'nctId': 'NCT04467892', 'briefTitle': 'Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia', 'organization': {'class': 'NETWORK', 'fullName': 'King Abdul Aziz Specialist Hospital'}, 'officialTitle': 'Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS', 'orgStudyIdInfo': {'id': 'ICU-11-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': '. Group A 120 patients, received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days', 'interventionNames': ['Drug: methylprednisolone', 'Device: ventilators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.', 'interventionNames': ['Drug: Methyl Prednisolonate', 'Device: ventilators']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days', 'armGroupLabels': ['Group A']}, {'name': 'Methyl Prednisolonate', 'type': 'DRUG', 'description': 'received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.', 'armGroupLabels': ['Group B']}, {'name': 'ventilators', 'type': 'DEVICE', 'description': 'all patients in both groups will be ventilated with CMV for 2 weeks', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21944', 'city': "Ta'if", 'country': 'Saudi Arabia', 'facility': 'King abd el Aziz specialist hospital', 'geoPoint': {'lat': 21.27028, 'lon': 40.41583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'medical doctors and intensivist'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdul Aziz Specialist Hospital', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}