Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT03216759
Status:
UNKNOWN
Last Update Posted:
2017-07-13
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of digestive system complications after operation', 'timeFrame': '12 hours to one week after surgery', 'description': 'The incidence of digestive system complications within one week after surgery'}, {'measure': 'The concentration of intestinal fatty acid-binding protein (I-FABP)', 'timeFrame': '12 h after operation', 'description': 'The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation'}], 'secondaryOutcomes': [{'measure': 'Postoperative heart and respiratory complications within one week', 'timeFrame': '12 hours to one week after surgery', 'description': 'Postoperative heart and respiratory complications within one week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Comprehensive intestinal protection strategy', 'Intestinal complications', 'laparotomy'], 'conditions': ['Intestinal Complications', 'Laparotomy']}, 'referencesModule': {'references': [{'pmid': '20484066', 'type': 'BACKGROUND', 'citation': 'Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.'}, {'pmid': '17707752', 'type': 'RESULT', 'citation': 'Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.', 'detailedDescription': 'Perioperative intestinal injury is one of the common tissues and organs injury in surgical practice. However, there is a lack of effective means of prevention and treatment.The investigators previously found that ischemic preconditioning, IPC, and dexmedetomidine has protective effects on intestinal mucosal injury.\n\nHowever, the combined effect of various factors has not been clinically validated. To explore the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia,the investigators select the patients undergoing open surgery under general anesthesia as the study subjects and the concentration of intestinal fatty acid binding protein (I-FABP) as well as the incidence of digestive system complications in one week after operation are the main observation indexes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 70 years;\n* Elective abdominal surgery under general anesthesia, operation time \\> 2h;\n* ASA Ⅰ \\~ Ⅲ;\n* Patient informed and consent to accept the test.\n\nExclusion Criteria:\n\n* persons under the age of 18 or over 70 years old;\n* pregnant or lactating women;\n* combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;\n* preoperative Hb \\<7g / l;\n* oral sulfa drugs or nicorandil antihypertensive drugs;\n* lower extremity amputees;\n* with peripheral vascular disease;\n* patients with mental illness or severe neurosis;\n* can not express the subjective symptoms;\n* nearly 3 months to participate in other drug clinical trials;\n* within 3 months of receiving other surgical treatment.'}, 'identificationModule': {'nctId': 'NCT03216759', 'acronym': 'CIPS', 'briefTitle': 'Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia', 'orgStudyIdInfo': {'id': 'CIPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Tourniquet would be tied to left upper limb of Patients who undergoing laparotomy for 30 minutes after the induction of anesthesia,but put no press on it. Other processes are consistent with conventional methods.'}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': "1. After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning.\n2. At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure.\n3. Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.", 'interventionNames': ['Procedure: Ischemic preconditioning', 'Drug: Dexmedetomidine', 'Procedure: Patient-controlled epidural analgesia']}], 'interventions': [{'name': 'Ischemic preconditioning', 'type': 'PROCEDURE', 'description': "After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.", 'armGroupLabels': ['intervention']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'At the beginning of anesthesia induction, 3 ug/kg/h of dexmedetomidine was infused and adjusted to 0.3 ug/kg/h after 10 min of infusion until 30 minutes before the end of the procedure.', 'armGroupLabels': ['intervention']}, {'name': 'Patient-controlled epidural analgesia', 'type': 'PROCEDURE', 'description': 'Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cai Li, M.D', 'role': 'CONTACT', 'email': 'licaisysu@163.com', 'phone': '+86-18602017796'}], 'overallOfficials': [{'name': 'Ke-Xuan Liu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, the Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Anesthesiology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Kexuan Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}