Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-09 @ 1:58 PM
Study NCT ID:
NCT02983851
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2016-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day all-cause mortality', 'timeFrame': 'the 30th day after patient inclusion in the study'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'through study study completion, an average of 2 years'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'through study study completion, an average of 2 years'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': 'through study study completion, an average of 2 years'}, {'measure': 'Nosocomial infections', 'timeFrame': 'through study study completion, an average of 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Noninvasive mechanical ventilation', 'Invasive mechanical ventilation'], 'conditions': ['Immunocompromised Patients', 'Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '28931394', 'type': 'DERIVED', 'citation': 'Wang T, Liu G, He K, Lu X, Liang X, Wang M, Zhu R, Li Z, Chen F, Ke J, Lin Q, Qian C, Li B, Wei J, Lv J, Li L, Gao Y, Wu G, Yu X, Wei W, Deng Y, Wang F, Zhang H, Zheng Y, Zhan H, Liao J, Tian Y, Yao D, Zhang J, Chen X, Yang L, Wu J, Chai Y, Shou S, Yu M, Xiang X, Zhang D, Chen F, Xie X, Li Y, Wang B, Zhang W, Miao Y, Eddleston M, He J, Ma Y, Xu S, Li Y, Zhu H, Yu X. The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM). BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.'}]}, 'descriptionModule': {'briefSummary': 'VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure.', 'detailedDescription': 'The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with moderate to severe acute respiratory failure (ARF). Patients who meet the indications for both ventilatory supports will be included. The intervention will consist of randomly allocation, treatment with NIV or IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity, causes of immunodeficiency and types of ARF will also be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years old ≤ age ≤ 80 years old) immunocompromised patients admitted to hospital with moderate to severe ARF diagnosed within the last 72 hours, which meets the indications for ventilatory support.\n* Patients are considered as moderate to severe ARF when the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) is between 85 and 170 while the patient is breathing oxygen through a Venturi mask, or clinically diagnosed as the following:\n\n 1. 30 mmHg \\< PaO2 \\< 50 mmHg on room air;\n 2. Clinical evidence of respiratory distress (intercostal recession, polypnea \\>35/min or dyspnea at rest).\n* Patients are considered as immunocompromised when clinically diagnosed as at least one of the following:\n\n 1. HIV infection;\n 2. Hematologic malignancy or solid tumor under chemotherapy;\n 3. Solid organ or stem cell transplant;\n 4. Long-term (\\>30 days) or high dose steroids (\\>1 mg/kg/d prednisone equivalent) usage and/or any other immunosuppressive drugs;\n 5. Neutropenia (defined as a neutrocyte count of \\< 0.50×109/L) showing for at least 48 hours\n\nExclusion Criteria:\n\n* Age\\<18 or \\>80 years old;\n* Partial pressure of arterial carbon dioxide (PaCO2) \\> 50 mmHg or arterial pH \\< 7.20;\n* PaO2/FiO2 \\>170 or PaO2/FiO2\\< 85;\n* Patients have been treated with NIV or IMV within 30 days.\n* NIV is contraindicated or IMV is definitely indicated, including PaO2/FiO2\\< 85, respiratory arrest, hemodynamic instability, inability to fit the face mask, pneumothorax, vomiting, development of airway bleeding, inability to protect the airway, or copious respiratory secretions;\n* Comorbided with other severe diseases, including New York Heart Association functional class ≥ II, valvular heart disease, dilated cardiomyopathy, cardiogenic pulmonary edema, implanted cardiac pacemaker, unstable angina, myocardial infarction, or cardiac surgery within the previous 3 months; systolic arterial pressure \\<90 mmHg after optimal fluid therapy; history of chronic obstructive pulmonary disease (COPD) or asthma; impaired consciousness (Glasgow Coma Scale score \\<13); postoperative acute respiratory failure; pregnancy or breastfeeding;\n* Lack of consent, do-not-intubate decision, and any other situations where obvious bias are expected'}, 'identificationModule': {'nctId': 'NCT02983851', 'briefTitle': 'Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'VENIM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive mechanical ventilation', 'description': 'Patients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment.', 'interventionNames': ['Procedure: Noninvasive mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Invasive mechanical ventilation', 'description': 'Patients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment.', 'interventionNames': ['Procedure: Invasive mechanical ventilation']}], 'interventions': [{'name': 'Noninvasive mechanical ventilation', 'type': 'PROCEDURE', 'description': 'Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.', 'armGroupLabels': ['Noninvasive mechanical ventilation']}, {'name': 'Invasive mechanical ventilation', 'type': 'PROCEDURE', 'description': 'Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.', 'armGroupLabels': ['Invasive mechanical ventilation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yi Li, M.D.', 'role': 'CONTACT', 'email': 'billliyi@126.com', 'phone': '13693109826'}], 'overallOfficials': [{'name': 'Yi Li, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'PUMC hospital,Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Health, China', 'class': 'OTHER_GOV'}, {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Cangzhou Central Hospital', 'class': 'OTHER'}, {'name': 'Handan First Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician of Emergency Department, professor', 'investigatorFullName': 'Yi Li, MD', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}