Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-28 @ 10:33 AM
Study NCT ID:
NCT04934904
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study adopted a randomized, open, blank control design, and did not blind researchers, patients or clinicians.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental Group:\n\nOn the basis of the clinical routine treatment of AGI in severe patients (gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy), the ultrasound-guided erector spinae plane block intervention is given.\n\nControlled Group:\n\nNormal Treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the cure rate of AGI', 'timeFrame': 'on the day3', 'description': 'the cure rate of AGI on the day3'}, {'measure': 'the cure rate of AGI', 'timeFrame': 'on the day7', 'description': 'the cure rate of AGI on the day7'}, {'measure': 'the remission rate of AGI', 'timeFrame': 'on the day3', 'description': 'the remission rate of AGI on the day3'}, {'measure': 'the remission rate of AGI', 'timeFrame': 'on the day7', 'description': 'the remission rate of AGI on the day7'}], 'secondaryOutcomes': [{'measure': 'Acute Physiology and Chronic Health Evaluation(APACHE II)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'measuring endpoints include:\n\nbody temperature\n\nmean arterial pressure (MAP)\n\nheart rate (HR)\n\nrespiratory rate (RR)\n\nfraction of inspiration O2 (FIO2)\n\npotential of hydrogen (PH)\n\nNa+\n\nK+\n\nserum creatinine (SCr)\n\nhematocrit (Hct%)\n\nwhite blood cell (WBC)\n\nAge\n\nimmunosuppression before/after surgery or serious organ dysfunction\n\n(Higher score means a worse outcome.)'}, {'measure': 'Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'SOFA score evaluate status of the following organ systems separately:\n\n(Higher score means a worse outcome.)\n\n1. Respiration Partial Pressure of Oxygen/Fraction of Inspiration O2 (PaO2/FiO2)\n2. Coagulation Platelets\n3. Liver Bilirubin\n4. Circulatory Mean arterial pressure\n5. Central Nervous System Glasgow coma score\n6. Renal Creatinine (or urine output)'}, {'measure': 'the intraperitoneal pressure(IAP)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'Gastrointestinal function indicators'}, {'measure': 'abdominal perfusion pressure(AAP)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'Gastrointestinal function indicators'}, {'measure': 'total gastric residual volume(GRVs)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'Gastrointestinal function indicators'}, {'measure': 'feeding dose', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'Gastrointestinal function indicators'}, {'measure': 'Gastrointestinal dysfunction and duration(GIF)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': '1. fasting(score 1 point)\n2. reflux(score 2 points)\n3. gastrointestinal decompression(1 point)\n4. Gastric retention(2 points)\n5. abdominal distension(2 points)\n6. abdominal pain(2 points)\n7. diarrhea(2 points)\n8. hypoactive bowel sounds(1 point)\n9. bowel sounds disappear(2 points)\n10. constipation(2 points)\n\nThe mentioned indicators will be combined to report GIF in score.\n\nGrade 0 (Normal) : 0 score\n\nGrade 1 (Mild) : 1\\~4 score\n\nGrade 2 (Medium) : 5\\~9 score\n\nGrade 3 (Serious) : \\>10 score'}, {'measure': 'Width of the colons', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'width of the right colons with abdominal X ray or CT'}, {'measure': 'White Blood Cell(WBC)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'Interleukin-6(IL-6)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'Cross-sectional area of pyloric antrum(AS)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'cross-sectional area of pyloric antrum(AS) with ultrasound'}, {'measure': 'Lymphocyte (LYM)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'Neutral Granular Cell(NEUT)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'Procalcitonin (PCT)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'Hypersensitive C Reactive Protein(HSCRP)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'The inflammatory indicators'}, {'measure': 'The lactic acid(Lac)', 'timeFrame': 'on the day 0,1,3 and 7', 'description': 'the serum level of the lactic'}, {'measure': 'The 28-day mortality', 'timeFrame': 'From enrolled to 28 days or the termination date', 'description': 'the 28-day mortality'}, {'measure': 'The length of stay in ICU', 'timeFrame': 'on the day 28 or through study completion', 'description': 'From the date of ICU admission to transfered out.'}, {'measure': 'The total days of hospitalization', 'timeFrame': 'on the day 28 or through study completion', 'description': 'from hospital admission to hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute gastrointestinal injury', 'Erector spinal muscle plane block', 'Ropivacaine'], 'conditions': ['Gastrointestinal Disease']}, 'descriptionModule': {'briefSummary': 'In this single-center, randomized, parallel control clinical trial, patients will be randomly assigned to two groups. The treatment group receives ultrasound-guided erector spinae plane block with routine treatment of Acute Gastrointestinal Injury (AGI) for 7 days or until transferred to the general ward, while the control group only receives routine treatment of AGI. The primary outcome is the cure and remission rate of AGI.', 'detailedDescription': 'Detailed Description:\n\nStudy title: The treatment of Acute Gastrointestinal Injury via ultrasound-guided erector spinae plane block - a prospective, single-center, randomized, controlled trial\n\nPrincipal Investigator: Professor Wang Hua, Department of Critical Care Unit, Zhujiang Hospital of Southern Medical University\n\nStudy subjects: Patients age from 18 to 80 with AGI Ⅱ or greater\n\nStudy phase: Investigator Initiated Trial(IIT)\n\nPrimary objectives:\n\nTo evaluate whether ultrasound-guided erector spinae plane block can reduce the grade of AGI , and improve the cure and remission rate of AGI.\n\nExperimental Group:\n\nOn the basis of routine clinical treatment, the ultrasound-guided erector spinae plane block intervention is given. On the first day enrolled, patients are performed with ultrasound-guided erector spinae plane block and cannula will be placed on T8 bilaterally. 0.375% ropivacaine of 20ml is injected separately to both sides with 2ml per hour. Injection is performed twice a day for 7 days or until transferred to the general ward.\n\nControlled Group:\n\nThe patients will receive the clinical routine treatment according of AGI recommended by the 2012 European Society of Critical Care Medicine guidelines, with a uniform nutritional strategy(gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy).\n\nCourse: 7 days Sample size: 100 Sites: 1\n\nPrimary endpoints:\n\n1. the cure rate of AGI\n2. the remission rate of AGI\n\nSecondary endpoints:\n\n1. critical ill scores\n2. Gastrointestinal function indicators\n3. The inflammatory indicators\n4. the lactic acid(Lac)\n5. cross-sectional area of pyloric antrum(AS) with ultrasound\n6. width of the colons with abdominal X ray or CT\n7. the 28-day mortality\n8. gastrointestinal dysfunction and duration (GIF)\n\nAdditional endpoints:\n\n1. The length of stay in ICU\n2. The total days of hospitalization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. AGI are diagnosed according to the diagnostic criteria proposed by European Society Intensive Care Medicine (ESICM) in 2012 and the AGI grade great than or equal to II.\n2. Age 18-80 years.\n3. Expected length of stay longer than 3 days.\n\nExclusion Criteria:\n\n1. Mean arterial pressure is still less than 65 millimeter of Mercury (mmHg) treated with rehydration and vasoactive agents, or with the dosage of norepinephrine more than 0.5ug/kg/min.\n2. Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.\n3. Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.\n4. Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.\n5. Neuromuscular disorders.\n6. Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.\n7. Pregnancy.\n8. Brain dead.\n9. Malignant tumor, or end-stage cachexia.\n10. With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.\n11. Allergy to local anesthetics.\n12. Significant abnormalities in blood coagulation parameters.\n13. Without written informed consent.'}, 'identificationModule': {'nctId': 'NCT04934904', 'briefTitle': 'The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '2020-KY-032-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'On the basis of the clinical routine treatment of AGI in severe patients, the Experimental Group will receives ultrasound-guided erector spinae plane block with routine treatment of AGI for 7 days or until transferring to the general ward.', 'interventionNames': ['Drug: Ropivacaine injection']}, {'type': 'NO_INTERVENTION', 'label': 'Controlled Group', 'description': 'the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy'}], 'interventions': [{'name': 'Ropivacaine injection', 'type': 'DRUG', 'otherNames': ['ropivacaine'], 'description': 'On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Hua Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}