Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 9:14 PM
Study NCT ID:
NCT02562105
Status:
COMPLETED
Last Update Posted:
2015-09-29
First Post:
2015-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-27', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-09-27', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associated comorbidities', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'Like as sepsis, acute respiratory distress syndorme, or leukopenia'}, {'measure': 'Cancer status', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'Early or advanced stage'}], 'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'through study completion, an average of 30 days after admission to intensive care unit', 'description': 'Continuing to live'}], 'secondaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment score', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'Sequential Organ Failure Assessment (SOFA) Score'}, {'measure': 'Simplified Acute Physiology Score II', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'Simplified Acute Physiology Score (SAPS II)'}, {'measure': 'Mode of mechanical ventilation', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'synchronised intermittent, pressure-controlled, volume-controlled, pressure support, continuous positive airway pressure, volume guarantee, adjusted pressure release ventilation, or adaptive proportional assist ventilation'}, {'measure': 'lowest Pa02/FiO2', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'PaO2 "arterial oxygen tension"/FiO2 "inspired fraction of oxygen" ratio'}, {'measure': 'Reason for need of ventilatory support', 'timeFrame': 'up to 24 hours after admission to the intensive care unit', 'description': 'Advanced malignancy, respiratory muscle weakness, respiratory failure, lung metastasis, coma, sepsis, multi-organs failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intensive care unit', 'Hematological malignancy', 'Acute respiratory failure', 'Prognosis', 'Mechanical ventilation'], 'conditions': ['Hematological Malignancy', 'Acute Respiratory Failure', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.', 'detailedDescription': "It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hematological cancer patients admitted to ICU of oncology center, Mansoura University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical ill hematological cancer patient\n* Requiring mechanical ventilation\n\nExclusion Criteria:\n\n* Patients with acute coronary syndrome.\n* Patients with cancer remission more than 5 years.'}, 'identificationModule': {'nctId': 'NCT02562105', 'briefTitle': 'Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'In a Developing Country; What is the Fate of Hematologic Cancer Patients Requiring Mechanical Ventilation for More Than One Day? A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '15.05.42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical ventilation', 'description': 'requiring mechanical ventilation at admission to ICU for one day or more during the study period', 'interventionNames': ['Procedure: Mechanical ventilation']}], 'interventions': [{'name': 'Mechanical ventilation', 'type': 'PROCEDURE', 'description': 'requiring mechanical ventilation at admission to ICU for one day or more during the study period', 'armGroupLabels': ['Mechanical ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura Cancer Therapy Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Dr.Enas A Abd El motlb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University, College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Enas Aly Abd El motlb', 'investigatorAffiliation': 'Mansoura University'}}}}