Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-30 @ 10:11 PM
Study NCT ID:
NCT05184959
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Immune Metabolism in Patients With Benzodiazepine Poisoning and Patients'Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D011041', 'term': 'Poisoning'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum obtained by centrfuge'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time interval', 'timeFrame': 'at admittion', 'description': 'Interval from benzodiazepine poisoning to emergency pre-examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['poisoning', 'benzodiazepines', 'neuro-immunity'], 'conditions': ['Poisoning by Benzodiazepines', 'Depression']}, 'descriptionModule': {'briefSummary': 'High-dose benzodiazepines can inhibit the central nervous system, respiratory system and cardiovascular motor center, resulting in loss of consciousness, disappearance of reflex, respiratory inhibition, decrease of blood pressure and so on. This kind of drug acute poisoning is the most common drug poisoning in internal medicine. It has acute onset and severe symptoms. If it is not treated properly in time, it can be life-threatening. At present, the research on the accumulation and metabolic state caused by benzodiazepine poisoning is not sufficient; at the same time, the changes of neuroendocrine metabolism and immune function of patients with neuroendocrine metabolism and immune function need to be further explored. Therefore, the main purpose of this study is to analyze the effects of neuroendocrine metabolism and immune function on organ function and mental state in patients with benzodiazepine poisoning.', 'detailedDescription': 'Benzodiazepines are the first choice for clinical anti-anxiety, sedation and hypnosis, as well as anticonvulsant, antiepileptic and central muscle relaxation. Commonly used are diazepam (diazepam), nitro diazepam, clonazepam, alprazolam, triazolam and so on. The drug itself is an inhibitor of the central nervous system, which has a high selectivity for the inhibition of the central nervous system, mainly inhibiting the limbic system of the brain and less inhibitory effect on the reticular ascending activation system. It mainly acts on the synaptic sites of GABA-Ergic nerve endings in the central nervous system. It enhances the affinity between GABA and its receptors by binding to benzodiazepine receptors, thus increasing the open frequency of Cl- channels coupled with GABA receptors and exerting an inhibitory effect. High-dose benzodiazepines can inhibit the central nervous system, respiratory system and cardiovascular motor center, resulting in loss of consciousness, disappearance of reflex, respiratory inhibition, decrease of blood pressure and so on. This kind of drug acute poisoning is the most common drug poisoning in internal medicine. It has acute onset and severe symptoms. If it is not treated properly in time, it can be life-threatening. At present, the research on the accumulation and metabolic state caused by benzodiazepine poisoning is not sufficient; at the same time, the changes of neuroendocrine metabolism and immune function of patients with neuroendocrine metabolism and immune function need to be further explored. Therefore, the main purpose of this study is to analyze the effects of neuroendocrine metabolism and immune function on organ function and mental state in patients with benzodiazepine poisoning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'posioning with Benzodiazepine along with at least one organ dysfucntion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBenzodiazepine poisoning Within 6 hours, at least one target organ dysfunction. No bad habits (drug use, alcohol addiction)\n\nExclusion Criteria:\n\nRefusal to join this study Lack of information/incompleteness Vulnerable groups such as pregnant women, incapable of civil conduct and indeterminate agent consent Chronic multiple organ dysfunction Tumors, blood system diseases, various systemic immune diseases Various infectious diseases (various hepatitis, tuberculosis, AIDS)'}, 'identificationModule': {'nctId': 'NCT05184959', 'briefTitle': "Correlation Between Immune Metabolism in Patients With Benzodiazepine Poisoning and Patients'Mental Disorders", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Correlation Between Early Neuro-immune Metabolism in Patients With Benzodiazepine Poisoning and Mental Disorders With Depression --- A Multiple Center Observational Study', 'orgStudyIdInfo': {'id': '2021-1069'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}