Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT06207461
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2023-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Medical ethics have yet to be passed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day survival rate (%)', 'timeFrame': 'Up to 4 weeks', 'description': 'Survival at 28 days after hospitalization'}, {'measure': 'Ultrasound assessment of gastrointestinal function: ACF (times/min)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Antral contraction frequency (ACF): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Within 6 minutes after infusion, divide the number of antral contractions by 3.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: ACA (%)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Antral contraction amplitude (ACA): Measure the area during 3 maximum relaxations (S relaxation) and minimum contractions (S contraction), calculate the change in antral area (ΔS = S relaxation - S contraction), and take the average of 3 measurements. Antral contraction amplitude: ΔS/S relaxation.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: MI', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Motility index (MI): ACF × ACA.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: GET (min)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Gastric emptying time (GET): In semi-recumbent position at 45°, infuse the stomach with 300ml of warm water. Use the maximum antral relaxation as the standard and measure the area every 5 minutes until the liquid in the antrum is emptied. The time it takes for the gastric antrum to empty is GET.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: intestinal wall thickness (mm)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Intestinal wall thickness of Jejunum/Ileum/Colon: Refers to the distance between the serosal and mucosal surfaces of the intestinal wall. The normal thickness of the small intestine is 2-3mm, and \\>3mm may indicate thickening of the intestinal wall; the thickness of the colon wall is approximately 3-4mm, and \\>5mm may suggest thickening of the intestinal wall. Attention should be paid to the colon pocket and the plica structure on the colon wall.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: intestinal diameter (cm)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Intestinal diameter of Jejunum/Ileum/Colon: When not under pressure, the measurement of the width of the small intestine often refers to the distance between the mucosal surfaces of the intestinal wall. The intestinal lumen width of the small intestine (jejunum/ileum) is generally \\<2cm, and \\>3cm may indicate intestinal dilation; the internal diameter of the colon is generally \\<5cm.'}, {'measure': 'Ultrasound assessment of gastrointestinal function: intestinal motility', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Intestinal motility of Jejunum/Ileum/Colon (yes or no): Under normal circumstances, intestinal movement can be clearly judged at the ultrasound interface. When the intestine is filled with gas or accompanied by intestinal dilation, intestinal motility can be judged by the "creeping gas sign" of the gas or the movement of the contents. In addition, attention should be paid to the intestinal motility caused by the pressure on the intestinal tube when moving the probe.'}], 'secondaryOutcomes': [{'measure': 'Daily amount of enteral nutrition feeding (ml)', 'timeFrame': 'Within 5 days after study inclusion', 'description': 'Daily amount of enteral nutrition feeding'}, {'measure': 'Daily gastric residual volume (ml)', 'timeFrame': 'Within 5 days after study inclusion', 'description': 'Daily gastric residual volume'}, {'measure': 'Serum levels of intestinal fatty acid binding protein (iFABP, ng/ml)', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Serum levels of iFABP measured by ELISA.'}, {'measure': 'Serum levels of citrulline (μmol/L)', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Serum levels of citrulline measured by ELISA.'}, {'measure': 'Serum levels of diamine oxidase (DAO, U/L)', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Serum levels of DAO measured by ELISA.'}, {'measure': 'Serum levels of D-lactic acid (mmol/L)', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Serum levels of D-lactic acid measured by ELISA.'}, {'measure': 'Superior mesenteric artery resistance index', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Superior mesenteric artery resistance index evaluated by ultrasound'}, {'measure': 'Intra-abdominal pressure (IAP) (mmHg)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Intra-abdominal pressure (IAP)'}, {'measure': 'Diarrhea', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Yes (numbers) or No'}, {'measure': 'Alimentary tract hemorrhage', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Yes (numbers) or No'}, {'measure': 'Prealbumin concentration (g/L)', 'timeFrame': '0, 72 and 120 hours after study inclusion', 'description': 'Serum levels of prealbumin'}, {'measure': 'Acute physiology and chronic health evaluation (APACHE) Ⅱ score', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': '0-67, higher scores correspond to more severe disease and a higher risk of death'}, {'measure': 'ICU length of stay (days)', 'timeFrame': 'Up to 4 weeks', 'description': 'ICU length of stay'}, {'measure': 'In-hospital mortality (%)', 'timeFrame': 'Up to 4 weeks', 'description': 'Mortality rate during hospitalization'}, {'measure': 'Peripheral venous blood CRP concentration (mg/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'CRP level measured by blood routine examination'}, {'measure': 'Peripheral venous blood hemoglobin concentration (g/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Hemoglobin level measured by blood routine examination'}, {'measure': 'Absolute number of white blood cells in the peripheral venous blood (number/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Absolute number of white blood cells measured by blood routine examination'}, {'measure': 'Absolute number of platelets in the peripheral venous blood (number/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Absolute number of platelets measured by blood routine examination'}, {'measure': 'Absolute number of lymphocytes in the peripheral venous blood (number/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Absolute number of lymphocytes measured by blood routine examination'}, {'measure': 'Whole blood pH', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Arterial pH measured by blood gas analysis'}, {'measure': 'Arterial PaO2 (mmHg)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Arterial PaO2 measured by blood gas analysis'}, {'measure': 'Arterial PaCO2 (mmHg)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Arterial PaCO2 measured by blood gas analysis'}, {'measure': 'Arterial bicarbonate (mmol/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Arterial bicarbonate measured by blood gas analysis'}, {'measure': 'Arterial lactic acid (mmol/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Arterial lactic acid measured by blood gas analysis'}, {'measure': 'Peripheral venous blood albumin concentration (g/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Albumin level measured by Blood biochemical examination'}, {'measure': 'Peripheral venous blood total bilirubin concentration (μmol/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Total bilirubin level measured by Blood biochemical examination'}, {'measure': 'Peripheral venous blood bound bilirubin concentration (μmol/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Bound bilirubin level measured by Blood biochemical examination'}, {'measure': 'Peripheral venous blood creatinine concentration (μmol/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'Creatinine level measured by Blood biochemical examination'}, {'measure': 'Peripheral venous blood ALT concentration (U/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'ALT level measured by Blood biochemical examination'}, {'measure': 'Peripheral venous blood AST concentration (U/L)', 'timeFrame': '0, 24, 48, 72, 96 and 120 hours after study inclusion', 'description': 'AST level measured by Blood biochemical examination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupoint massage', 'Gastrointestinal dysfunction', 'Gastrointestinal function recovery', 'Intensive care unit', 'Intestinal barrier'], 'conditions': ['Traditional Chinese Acupoint Message', 'Intestinal Barrier', 'Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': 'Patients in the intensive care unit (ICU) are often at risk of gastrointestinal dysfunction and malnutrition. Gastrointestinal dysfunction was associated with poor clinical outcomes, including prolonged mechanical ventilation, prolonged ICU stay and increased 90-day mortality.\n\nThere have been some clinical studies investigating the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on gastrointestinal function recovery. Gastrointestinal dysfunction could be improved by stimulating single acupoint or combining multiple acupoints, and the effects of combined stimulation of multiple acupoints was better for the improvement of gastrointestinal dysfunction.\n\nThis project aims to study the effects of traditional Chinese acupoint massage, acupuncture, or moxibustion of 7 acupoints (Zhongwan Point (CV12), Tianshu Point (ST25), Qihai Point (CV6), Zusanli point (ST36), Shangjuxu Point (ST37), Neiguan Point (PC6) and Hegu Point (LI4)) on the 28-day survival, and the gastrointestinal function recovery in critically ill patients with with gastrointestinal dysfunction caused by medical diseases and critically ill patients with high risk of malnutrition in ICU, and to observe their effects on the recovery of gastrointestinal barrier function by measuring the serum intestinal fatty acid binding protein (iFABP), citrulline, diamine oxidase (DAO) and D-lactic acid. Studies have shown that serum iFABP, citrulline, DAO and D-lactic acid could reflect the intestinal barrier function of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult critically ill patients at high risk of malnutrition due to gastrointestinal functional impairment caused by medical diseases in the ICU, and AGI grade I-II or NRS 2002 score ≥3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;\n2. Patients with high risk of malnutrition due to gastrointestinal dysfunction caused by medical diseases, and AGI score Ⅰ-Ⅱ or NRS 2002 score ≥3 points;\n3. Patients with hospital stay longer than 120 hours;\n4. Willing to participate in this trial.\n\nExclusion Criteria:\n\n1. Patients with abdominal open trauma;\n2. Defects, infections or lesions in the skin near the acupoints；\n3. Patients with abdominal tumor or large amount of abdominal fluid;\n4. Patients with AGI score Ⅲ or above;\n5. Pregnant patients;\n6. Patients with Child-Pugh grade B and grade C liver function\n7. Unable or unwilling to provide informed consent or poor compliance.'}, 'identificationModule': {'nctId': 'NCT06207461', 'briefTitle': 'Traditional Chinese Acupoint Massage for Gastrointestinal Function Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Effects of Traditional Chinese Acupoint Massage on Gastrointestinal Function Recovery of ICU Patients: a Single-center, Prospective, Non-blind, Randomized Study', 'orgStudyIdInfo': {'id': 'ZJC202401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'massage group', 'description': 'patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got massage'}, {'label': 'non-massage group', 'description': 'patients with gastrointestinal function injury caused by medical diseases or with high risk of malnutrition who got no massage'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Jiancheng Zhang', 'investigatorFullName': 'Jiancheng Zhang', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}