Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 9:02 PM
Study NCT ID:
NCT06452966
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008516', 'term': 'Medicine, Chinese Traditional'}], 'ancestors': [{'id': 'D008518', 'term': 'Medicine, East Asian Traditional'}, {'id': 'D008519', 'term': 'Medicine, Traditional'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a non-randomized real world data'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensive care unit length of stay', 'timeFrame': '"through study completion, an average of 3 months".', 'description': 'the number of days a patient stays in the Intensive care unit'}, {'measure': 'hospital length of stay', 'timeFrame': '"through study completion, an average of 3 months".', 'description': 'The number of days a patient stays in the hospital'}, {'measure': 'Mechanical ventilation time', 'timeFrame': '"through study completion, an average of 3 months".', 'description': 'The number of days a patient requires mechanical ventilation'}, {'measure': 'Respiratory care center stay', 'timeFrame': '"through study completion, an average of 3 months".', 'description': 'The number of days a patient stays in the respiratory care center'}, {'measure': 'Patient survival and mortality', 'timeFrame': '"through study completion, an average of 1 year".', 'description': 'Measure ICU, RCC, and hospital mortality'}], 'secondaryOutcomes': [{'measure': 'Kidney function', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Measured by blood urea nitrogen (BUN)'}, {'measure': 'Creatinine (creatinine)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Creatinine (creatinine) levels in blood sample'}, {'measure': 'Daily urine output', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Daily urine output in ml'}, {'measure': 'Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Daily intake Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.'}, {'measure': 'Number of days to reach 80% of target energy expenditure.', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Daily intake, number of days out of the first 14 days the patients reach 80% of target energy expenditure.'}, {'measure': 'Number of days to reach 100% of target energy expenditure.', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Daily intake Number of days out of the first 14 days the patients reach100% of target energy expenditure.'}, {'measure': 'Oxygenation index', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'FiO2 rate in ventilator'}, {'measure': 'PaO2 rate', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'patients PaO2 rate in ventilator'}, {'measure': 'Respirator parameters', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Tidal volume (VT) in ventilator'}, {'measure': 'Positive end-expiratory pressure (PEEP)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Positive end-expiratory pressure (PEEP) in ventilator'}, {'measure': 'Respiratory rate (RR)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Respiratory rate (RR) in ventilator'}, {'measure': "Inspiratory airflow (V')", 'timeFrame': 'baseline, day 1-14 of the study', 'description': "Inspiratory airflow (V') in ventilator"}, {'measure': 'Alanine transaminase (ALT)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Alanine transaminase (ALT) levels in blood sample'}, {'measure': 'Liver function', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Aspartate transaminase (AST) levels in blood sample'}, {'measure': 'Alkaline phosphatase (ALP),', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Alkaline phosphatase (ALP), levels in blood sample'}, {'measure': 'Albumin', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Albumin levels in blood sample'}, {'measure': 'total protein', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'total protein levels in blood sample'}, {'measure': 'Bilirubin,', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Bilirubin, levels in blood sample'}, {'measure': 'L-lactate dehydrogenase (LD)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'L-lactate dehydrogenase (LD) levels in blood sample'}, {'measure': 'Prothrombin time (PT)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Prothrombin time (PT)'}, {'measure': 'Cardiovascular function', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Measured by blood pressure'}, {'measure': 'use of vasopressors.', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Measured by use of vasopressors.'}, {'measure': 'Glasgow Coma Scale (GCS)', 'timeFrame': 'baseline, day 1-14 of the study', 'description': 'Glasgow Coma Scale (GCS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'chinese medicine', 'Organ Failure', 'intensive care'], 'conditions': ['Organ Failure, Multiple', 'Indigestion', 'Delayed Gastric Emptying', 'Respiratory Failure', 'Morality']}, 'descriptionModule': {'briefSummary': 'Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).\n\nThe goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks.\n\nA multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023).\n\nMain outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.', 'detailedDescription': 'Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).\n\nA multi center non-randomized real word data study, will include 3 groups: intervention group (n=70), control group (patients recruited enrolled to the ICU during the study period) and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). The intervention group will receive traditional Chinese herbal medicine and/or acupuncture and/or low level laser applied on acupuncture points depending on TCM doctor decision and patient TCM diagnosis. Intervention period will be 2 weeks.\n\nMain outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 20 and above\n* Surgical ICU patients\n* The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit\n\nExclusion criteria:\n\n* Patients' family members refuse TCM intervention"}, 'identificationModule': {'nctId': 'NCT06452966', 'briefTitle': 'The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'CMUH113-REC3-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': "patients in the group will recived one of or a combination of the following intervantions:\n\n1. Oral Chinese medicine decoction:\n\n The Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a day, for two weeks.\n2. Acupuncture or low level laser acupuncture treatment:\n\nChinese medicine practitioners select acupuncture points for treatment based on the patient's condition and treat them twice a week for 20 minutes each time for a total of two weeks.\n\nthe intervantion depents on the TCM doctor decision based on the patient's diagnosis and needs.\n\nin addition, the patients will recive ICU care and medication based on patient's needs.", 'interventionNames': ['Other: traditional Chinese medicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'the patients in this group will receive routine ICU care. the patients will be recruted during the study period. the patients will not recive TCM intervantions.', 'interventionNames': ['Other: Routine ICU care']}, {'type': 'OTHER', 'label': 'Historical control', 'description': 'Patients admitted to the same ICU in the period of 01.2019 to 12.2023. the patients did not recivied TCM intervantions', 'interventionNames': ['Other: historical Routine ICU care']}], 'interventions': [{'name': 'traditional Chinese medicine', 'type': 'OTHER', 'otherNames': ['Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture'], 'description': "patients in the group will receive one of or a combination of the following interventions:\n\nOral Chinese medicine decoction:\n\nThe Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a day, for two weeks.\n\nAcupuncture or low level laser acupuncture treatment:\n\nChinese medicine practitioners select acupuncture points for treatment based on the patient's condition and treat them twice a week for 20 minutes each time for a total of two weeks.\n\nthe intervantion depents on the TCM doctor decision based on the patient's diagnosis and needs.\n\nin addition, the patients will recive ICU care and medication based on patient's needs.", 'armGroupLabels': ['intervention group']}, {'name': 'Routine ICU care', 'type': 'OTHER', 'otherNames': ['ICU care'], 'description': 'Patients will receive ICU care', 'armGroupLabels': ['control group']}, {'name': 'historical Routine ICU care', 'type': 'OTHER', 'otherNames': ['Routine ICU care'], 'description': 'Patients had received ICU care', 'armGroupLabels': ['Historical control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Chen Lee, PHD', 'role': 'CONTACT', 'email': '005167@tool.caaumed.org.tw'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Yu-Chen Lee, M.D.,PhD', 'role': 'CONTACT', 'email': '005167@tool.caaumed.org.tw', 'phone': '886-975-682023'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}