Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT01172132
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2010-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival status at one year', 'timeFrame': '1 year', 'description': 'survival status (alive or death) at one year'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life of patients and their relatives', 'timeFrame': 'day 90 and 1 year'}, {'measure': 'ICU mortality', 'timeFrame': '1 week (estimated mean time until ICU discharge)', 'description': 'survival status at ICU discharge'}, {'measure': 'Survival status', 'timeFrame': 'day 90'}, {'measure': 'Hospital mortality', 'timeFrame': '3 weeks (estimated mean time until Hospital discharge)', 'description': 'survival status at hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leukemia', 'Lymphoma', 'Bone-Marrow Transplant', 'Neutropenia', 'Acute respiratory failure', 'Mechanical ventilation', 'Post ICU burden', 'ICU triage', 'Dialysis', 'Septic shock'], 'conditions': ['Hematological Malignancies']}, 'referencesModule': {'references': [{'pmid': '20392286', 'type': 'BACKGROUND', 'citation': 'Camous L, Lemiale V, Canet E, Max A, Schnell D, Le Goff J, Rabbat A, Schlemmer B, Azoulay E. Clinical features of H1N1 2009 infection in critically ill immunocompromised patients. Crit Care. 2010;14(2):139. doi: 10.1186/cc8927. Epub 2010 Apr 14.'}, {'pmid': '26429355', 'type': 'RESULT', 'citation': 'Lemiale V, Resche-Rigon M, Mokart D, Pene F, Rabbat A, Kouatchet A, Vincent F, Bruneel F, Nyunga M, Lebert C, Perez P, Meert AP, Benoit D, Chevret S, Azoulay E. Acute respiratory failure in patients with hematological malignancies: outcomes according to initial ventilation strategy. A groupe de recherche respiratoire en reanimation onco-hematologique (Grrr-OH) study. Ann Intensive Care. 2015 Dec;5(1):28. doi: 10.1186/s13613-015-0070-z. Epub 2015 Sep 30.'}, {'pmid': '29474336', 'type': 'DERIVED', 'citation': "Zafrani L, Resche-Rigon M, De Freitas Caires N, Gaudet A, Mathieu D, Parmentier-Decrucq E, Lemiale V, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, N'yunga M, Bruneel F, Rabbat A, Lebert C, Perez P, Meert AP, Benoit D, Darmon M, Azoulay E. Endothelial Cell-Specific Molecule-1 in Critically Ill Patients With Hematologic Malignancy. Crit Care Med. 2018 Mar;46(3):e250-e257. doi: 10.1097/CCM.0000000000002934."}, {'pmid': '27783381', 'type': 'DERIVED', 'citation': 'Contejean A, Lemiale V, Resche-Rigon M, Mokart D, Pene F, Kouatchet A, Mayaux J, Vincent F, Nyunga M, Bruneel F, Rabbat A, Perez P, Meert AP, Benoit D, Hamidfar R, Darmon M, Jourdain M, Renault A, Schlemmer B, Azoulay E. Increased mortality in hematological malignancy patients with acute respiratory failure from undetermined etiology: a Groupe de Recherche en Reanimation Respiratoire en Onco-Hematologique (Grrr-OH) study. Ann Intensive Care. 2016 Dec;6(1):102. doi: 10.1186/s13613-016-0202-0. Epub 2016 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine:\n\n* Condition of intensive care unit (ICU) admission in patients with haematological malignancies.\n* ICU hospital and up to one year mortality.\n* Assessment of post ICU burden and health related quality at 90-d and 1 year.', 'detailedDescription': "1. To identify prognostic factors of short and medium term mortality, by underlining the respective weights of organ dysfunction and characteristics of underlined malignancy\n2. Evaluate the health related quality of life of intensive care survivors(SF36)\n3. Impact of intensive care on families burden (HADS, IES).\n4. Assess clinicians' satisfaction ( intensivists, haematologists and intensive care nurses) in relation to medical decision-making.\n5. Establish the relevance of antifungal treatments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heamatological malignancy adressed to ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hematological malignancies\n* hospitalization in ICU\n* age \\>= 18 years\n\nExclusion Criteria:\n\n* Patients who have already participated to TRIAL-OH'}, 'identificationModule': {'nctId': 'NCT01172132', 'briefTitle': 'The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH"', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Long Term Outcomes in Critically Ill Haematological Patients. The Use of Intensive Care in Critically Ill Cancer Haematological Patients', 'orgStudyIdInfo': {'id': 'AOM 08235'}}, 'contactsLocationsModule': {'locations': [{'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Elie Azoulay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Louis Hospital, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}