Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-09 @ 6:32 AM
Study NCT ID:
NCT04358133
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled, parallel-group,single center, phase 2 pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average dyspnea over 24 hours', 'timeFrame': 'systematically evaluated every 4 hours over 24 hours and whenever necessary', 'description': 'Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).'}], 'secondaryOutcomes': [{'measure': 'Intensity of dyspnea', 'timeFrame': 'every 4 hours over 24 hours', 'description': 'patient reported outcome measure (PRO) ; min=0;max=100(worse)'}, {'measure': 'Incidence of severe dyspnea (dyspnea ≥40)', 'timeFrame': 'within 24 hours', 'description': 'patient reported outcome measure (PRO) ; min=0;max=100(worse)'}, {'measure': 'Anxiety', 'timeFrame': 'every 4 hours as well as over the first 24 hours', 'description': 'Patient reported outcome measure (PRO) ; min=0;max=100(worse)'}, {'measure': 'Incidence of moderate to severe anxiety', 'timeFrame': 'every 4 hours over 24 hours', 'description': 'Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse)'}, {'measure': 'Intubation rate', 'timeFrame': 'within the first 48 hours', 'description': 'Intubation rate'}, {'measure': 'Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12)', 'timeFrame': 'every 4 hours as well as the first 48 hours', 'description': 'Vigilance level ; GCS : min=3(worse) ;max=15'}, {'measure': 'Incidence of coma', 'timeFrame': 'within the first 48 hours', 'description': 'Incidence of coma'}, {'measure': 'Incidence of delirium', 'timeFrame': 'within the first every 4 hours as well as over the first 48 hours', 'description': 'Incidence of delirium'}, {'measure': 'Respiratory rate', 'timeFrame': 'every 4 hours as well as over the first 24 hours', 'description': 'Respiratory rate'}, {'measure': 'Proportion of patients requiring the transition from one oxygenation technique to another', 'timeFrame': 'At the end of the study (12 months)', 'description': 'Proportion of patients requiring the transition from one oxygenation technique to another'}, {'measure': 'Intensity of pain', 'timeFrame': 'every 4 hours', 'description': 'Patient reported outcome measure (PRO) ; min=0;max=100(worse)'}, {'measure': 'Duration of night sleep the first night', 'timeFrame': 'at the end of the first night', 'description': 'Duration of night sleep the first night (number of hours)'}, {'measure': 'Quality of sleep the first night', 'timeFrame': 'at the end of the first night', 'description': 'Patient reported outcome measure (PRO); min=0;max=100(worse)'}, {'measure': 'Severity of dry eye', 'timeFrame': 'in the first 24 hours', 'description': 'Patient reported outcome criteria (PRO); min=0;max=100(worse)'}, {'measure': 'Severity of dry nose', 'timeFrame': 'in the first 24 hours', 'description': 'Patient reported outcome criteria (PRO); min=0;max=100(worse)'}, {'measure': 'Severity of feeling of gastric distension', 'timeFrame': 'in the first 24 hours', 'description': 'Patient reported outcome criteria (PRO); min=0;max=100(worse)'}, {'measure': 'Constipation', 'timeFrame': 'in the first 48 hours', 'description': 'Constipation (PRO); min=0;max=100(worse)'}, {'measure': 'Nausea', 'timeFrame': 'in the first 48 hours', 'description': 'Patient reported outcome criteria (PRO) ;min=0;max=100(worse)'}, {'measure': "Nurses' adherence to the protocol", 'timeFrame': 'in the first 24 hours', 'description': "Nurses' adherence to the protocol (questionnaire)"}, {'measure': "Nurses' satisfaction with the protocol", 'timeFrame': 'in the first 24 hours', 'description': "Nurses' satisfaction with the protocol (questionnaire)"}, {'measure': 'Number of non invasive ventilation sessions', 'timeFrame': 'in the first 24 hours', 'description': 'Number of non invasive ventilation sessions'}, {'measure': 'Total duration of non invasive ventilation', 'timeFrame': 'in the first 24 hours', 'description': 'Total duration of non invasive ventilation (number of hours)'}, {'measure': 'Tolerance of non invasive ventilation', 'timeFrame': 'in the first 24 hours', 'description': 'Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse)'}, {'measure': 'Duration of HFNCO (high-flow nasal canula oxygenation)', 'timeFrame': 'in the first 24 hours', 'description': 'Duration of HFNCO (number of hours)'}, {'measure': 'Tolerance of HFNCO(high-flow nasal canula oxygenation)', 'timeFrame': 'in the first 24 hours', 'description': 'Tolerance of HFNCO : number of adverses events'}, {'measure': 'Duration of standard oxygen', 'timeFrame': 'in the first 24 hours', 'description': 'Duration of standard oxygen (number of hours)'}, {'measure': 'Tolerance of standard oxygen', 'timeFrame': 'in the first 24 hours', 'description': 'Tolerance of standard oxygen : number of adverses events'}, {'measure': 'Any adverse or serious event occurring', 'timeFrame': 'within the first 48 hours', 'description': 'Any adverse or serious event occurring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Dyspnea', 'Opioids', 'Comfort', 'Intensive care unit'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '39014448', 'type': 'DERIVED', 'citation': 'Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Mayaux J, Similowski T, Dechartres A, Demoule A. Low dose of morphine to relieve dyspnea in acute respiratory failure: the OpiDys double-blind randomized controlled trial. Respir Res. 2024 Jul 16;25(1):280. doi: 10.1186/s12931-024-02867-2.'}, {'pmid': '36175968', 'type': 'DERIVED', 'citation': 'Demoule A, Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Similowski T, Dechartres A. Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study. Trials. 2022 Sep 30;23(1):828. doi: 10.1186/s13063-022-06754-3.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified.\n\nThe study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.', 'detailedDescription': 'Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot study.The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated morphine (experimental group) and placebo (control group). The other treatments will be similar in both groups, according to the protocol and the recommendations.\n\nSevere dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse events for 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≤ 75 years\n* Admitted in intensive care for an acute respiratory failure defined as a respiratory rate\\> 24 / min or signs of respiratory distress such as labored breathing or paradoxical inspiration, or SpO2 \\<90% in ambient air\n* Spontaneous ventilation, either under standard oxygen, high flow oxygen or non invasive ventilation\n* Dyspnea ≥ 40 on an dyspnea-VAS from zero (no dyspnea) to 100 (worst possible dyspnea)\n* Richmond agitation and sedation scale (RASS) between 0 and 2.\n* No confusion, as defined by the CAM-ICU\n* Signed informed consent\n\nExclusion Criteria:\n\n* Intubated patient\n* Intubation planned upon admission\n* Hearing or visual impairment\n* Insufficient command of French\n* Previous psychiatric or cognitive disorders known\n* Moribund patient\n* Known hypersensitivity to opioids\n* Severe renal insufficiency (creatinine clearance \\<30 ml / min)\n* Severe hepatocellular insufficiency (factor V \\<50%)\n* Any formal contra-indication of opiates\n* Opioid use within the 24 hours before inclusion\n* Pregnancy or breastfeeding\n* Minor and protected adult\n* Exclusion period due to inclusion in another clinical trial\n* Previous inclusion in this study\n* No affiliation to social security'}, 'identificationModule': {'nctId': 'NCT04358133', 'acronym': 'OPIDYS', 'briefTitle': 'Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Relieving Dyspnea With Low Dose of Morphine in Patients Admitted to the Intensive Care Unit for an Acute Respiratory Failure: a Double-blind Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'CRC18023'}, 'secondaryIdInfos': [{'id': '2019-003091-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhydrate de morphine', 'description': 'initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \\<40 then relay subcut', 'interventionNames': ['Drug: Chlorhydrate de morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0,9%', 'description': 'initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \\<40 then relay subcut', 'interventionNames': ['Drug: NaCl 0,9%,']}], 'interventions': [{'name': 'Chlorhydrate de morphine', 'type': 'DRUG', 'description': 'The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol', 'armGroupLabels': ['Chlorhydrate de morphine']}, {'name': 'NaCl 0,9%,', 'type': 'DRUG', 'description': 'The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm', 'armGroupLabels': ['NaCl 0,9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alexandre DEMOULE, PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.\n\nConsultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}