Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-11 @ 12:57 AM
Study NCT ID:
NCT01760967
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2012-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-25', 'studyFirstSubmitDate': '2012-12-26', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'on 28 days', 'description': 'mortality of patients on 28 days or on a day of discharge if patients are discharged earlier than 28 days'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'up to 28 days', 'description': 'duration of mechanical ventilation in the ICU involving non-invasive ventilation'}], 'secondaryOutcomes': [{'measure': 'length of stay in the ICU', 'timeFrame': 'up to 28 days'}, {'measure': 'length of stay in the hospital', 'timeFrame': 'up to 28 days'}, {'measure': 'Evaluation of restlessness and delirium', 'timeFrame': 'up to 28 days in the ICU', 'description': 'evaluation of Richmond agitation-sedation scale (RASS) and Confusion Assessment Method for ICU patients (CAM-ICU)'}, {'measure': 'Evaluation of cognitive function', 'timeFrame': 'on 28 days or on the day of discharge', 'description': 'evaluation of Mini mental state examination (MMSE) on the 28 days or on a day of discharge if patients are discharged earlier than 28 days'}, {'measure': 'Occurrence of arrythmia or myocardial ischemia', 'timeFrame': 'up to 28 days in the ICU'}, {'measure': 'Renal function', 'timeFrame': 'up to 28 days in the ICU', 'description': 'blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR), daily urinary output, need of renal replacement therapy'}, {'measure': 'infection control', 'timeFrame': 'within 28 days until discharge', 'description': 'Duration of antimicrobial agents use within 28 days or a day of discharge if patients are discharged earlier than 28 days'}, {'measure': 'inflammation marker', 'timeFrame': 'for 14days', 'description': 'Laboratory marker of inflammation (CRP, PCT) on 1,3,7,14 days'}, {'measure': 'organ failure control', 'timeFrame': 'up to 28 days in the ICU', 'description': 'Sequential Organ Failure Assessment (SOFA) score during in the ICU'}, {'measure': 'coagulopathy control', 'timeFrame': 'for 14 days', 'description': 'Disseminated Intravascular Coagulation (DIC) score by the Japanese Association for Acute Medicine during in the ICU'}, {'measure': 'nutrition control', 'timeFrame': 'up to 28 days in the ICU', 'description': 'daily energy intake by enteral nutrition'}, {'measure': 'sedation control', 'timeFrame': 'up to 28 days in the ICU', 'description': 'dose of sedative drugs and analgesic drugs during in the ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'sepsis', 'mortality', 'duration of mechanical ventilation', 'organ failure'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '32778146', 'type': 'DERIVED', 'citation': 'Ohta Y, Miyamoto K, Kawazoe Y, Yamamura H, Morimoto T. Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial. Crit Care. 2020 Aug 10;24(1):493. doi: 10.1186/s13054-020-03207-8.'}, {'pmid': '31908779', 'type': 'DERIVED', 'citation': 'Nakashima T, Miyamoto K, Shima N, Kato S, Kawazoe Y, Ohta Y, Morimoto T, Yamamura H; DESIRE Trial Investigators. Dexmedetomidine improved renal function in patients with severe sepsis: an exploratory analysis of a randomized controlled trial. J Intensive Care. 2020 Jan 2;8:1. doi: 10.1186/s40560-019-0415-z. eCollection 2020.'}, {'pmid': '29497535', 'type': 'DERIVED', 'citation': 'Yamamura H, Kawazoe Y, Miyamoto K, Yamamoto T, Ohta Y, Morimoto T. Effect of norepinephrine dosage on mortality in patients with septic shock. J Intensive Care. 2018 Feb 26;6:12. doi: 10.1186/s40560-018-0280-1. eCollection 2018.'}, {'pmid': '28322414', 'type': 'DERIVED', 'citation': 'Kawazoe Y, Miyamoto K, Morimoto T, Yamamoto T, Fuke A, Hashimoto A, Koami H, Beppu S, Katayama Y, Itoh M, Ohta Y, Yamamura H; Dexmedetomidine for Sepsis in Intensive Care Unit Randomized Evaluation (DESIRE) Trial Investigators. Effect of Dexmedetomidine on Mortality and Ventilator-Free Days in Patients Requiring Mechanical Ventilation With Sepsis: A Randomized Clinical Trial. JAMA. 2017 Apr 4;317(13):1321-1328. doi: 10.1001/jama.2017.2088.'}, {'pmid': '27716402', 'type': 'DERIVED', 'citation': 'Rudiger A, Singer M. Decatecholaminisation during sepsis. Crit Care. 2016 Oct 4;20(1):309. doi: 10.1186/s13054-016-1488-x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nDexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU sedation in 2004 in Japan, and it has been used particularly for surgical ICU patients. In August 2010 dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.\n\nRecent evidence demonstrated that dexmedetomidine has organ protective effects including neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning effect against ischemic injury in hippocampal slices, and this result was considered an apoptosis suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine enhanced the spontaneous contractions of the ileum in peritonitis rats compared with propofol and midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha in endotoxemic rats.\n\nA meta-analysis has shown that perioperative alfa2-adrenergic agonists, including dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine output, reduction in serum creatinine, and the suppression of diuretics in a randomized placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had improved 28-day mortality rates compared with septic patients receiving lorazepam in a sub-group analysis of MENDS randomized controlled trial.\n\nThese positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys, gastrointestinal tract action, and an anti-inflammatory action, are expected to improve mortality in septic patients. However, large clinical research studies have not been conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical outcome and has these organ protective effects on septic patients.\n\nObjective:\n\nTo determine whether dexmedetomidine improves clinical outcome and has organ protective effects on septic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult\n* transferred to ICU\n* anticipation of a need for mechanical ventilation at least 24 hours\n\nExclusion Criteria:\n\n* sever chronic liver disease (Child B or C)\n* acute myocardial infarction, heart disease (NYHA 4)\n* Drug dependence, alcoholism\n* Psychological illness, severe cognitive dysfunction\n* patients who have allergy for dexmedetomidine\n* attending physician's decision"}, 'identificationModule': {'nctId': 'NCT01760967', 'acronym': 'DESIRE', 'briefTitle': 'Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'Effect of Dexmedetomidine on Mortality, Duration of Mechanical Ventilation and Multi-organ Function in Sepsis Patients Under Lighter Sedation by Randomized Control Trial', 'orgStudyIdInfo': {'id': 'DESIRE'}, 'secondaryIdInfos': [{'id': 'UMIN000009665', 'type': 'OTHER', 'domain': 'UMIN-CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'administer dexmedetomidine (0.1-0.7ug/kg/h) from the beginning of ICU treatment', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-Dexmedetomidine', 'description': 'administer sedatives except Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'intervention to administer dexmedetomidine or not', 'armGroupLabels': ['Dexmedetomidine', 'non-Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9808574', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku University', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}], 'overallOfficials': [{'name': 'Yu Kawazoe', 'role': 'STUDY_CHAIR', 'affiliation': 'Tohoku University'}, {'name': 'Hitoshi Yamamura, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hirosaki University'}, {'name': 'Takeshi Morimoto, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hyogo Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osaka City University', 'class': 'OTHER'}, {'name': 'Hyogo Medical University', 'class': 'OTHER'}, {'name': 'Osaka City General Hospital', 'class': 'OTHER'}, {'name': 'National Hospital Organization Kyoto Medical Center', 'class': 'UNKNOWN'}, {'name': 'Saga University', 'class': 'OTHER'}, {'name': 'Yamaguchi Grand Medical Center', 'class': 'UNKNOWN'}, {'name': 'Sapporo Medical University', 'class': 'OTHER'}, {'name': 'Tohoku University', 'class': 'OTHER'}, {'name': 'Hirosaki University', 'class': 'OTHER'}, {'name': 'Kyoto Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yu Kawazoe', 'investigatorAffiliation': 'Tohoku University'}}}}