Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-07 @ 11:33 AM
Study NCT ID:
NCT05641792
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring for Emergency Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of CGM system', 'timeFrame': '10 days', 'description': 'measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.'}], 'secondaryOutcomes': [{'measure': 'intra- and post-operative glycemia', 'timeFrame': '10 days', 'description': 'number of hyperglycemia episodes'}, {'measure': 'postoperative morbidity', 'timeFrame': '30 days', 'description': "all types of postoperative complications and their severity according to Clavien-Dindo scale (grade I to V; grade I represents any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention and grade 5 represents patient's death)"}, {'measure': 'SSI rate', 'timeFrame': '30 days', 'description': 'Surgical Site Infection according to Centre for Disease Control criteria:\n\nInfection occurring within the first 30 post-operative days with at least one of the following:\n\n* Purulent drainage from the incision\n* Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision\n* Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection:\n\n 1. Pain or tenderness\n 2. Localized swelling\n 3. Redness\n 4. Heat\n* Diagnosis of SSI by the surgeon or attending physician\n\nDue to the inability to implement CDC for wounds treated with NPWT, the investigators have included additional SSI criteria: the absolute necessity to prolong NPWT after 3rd day postop, an anergic wound morphology or slough.'}, {'measure': 'effective wound closure', 'timeFrame': '30 days', 'description': 'definitive wound closure, not followed by wound dehiscence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['continuous glucose monitoring', 'CGM', 'Dexcom G6'], 'conditions': ['Peritonitis', 'Surgical Site Infection', 'Infections', 'Hyperglycemia', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'CLUE trial aims to determine the feasibility and predictive value for surgical site infection (SSI) of continuous glucose monitoring (CGM) in emergency laparotomy patients with diffuse peritonitis.', 'detailedDescription': 'Hyperglycaemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. Therefore, the investigators predict that number of hyperglycaemia episodes could be a predictor of SSI.\n\nContinuous glucose monitoring allows for a minimally invasive real-time remote glycemia control, yet it has not been applied in an emergency surgery setting. Intraoperative glycemia monitoring would allow to determine the effect of specific interventions during a surgical procedure that may provoke hyperglycaemia.\n\nCLUE is a single-centre prospective observational study held in an academic tertiary medical centre in Poland. Adult patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery, with class ≥ III wounds according to Centers for Disease Control and Prevention (CDC) classification, will be eligible for the CLUE trial. Patients who will be unable or will refuse to express informed consent will be excluded. Patients will be co-enrolled in PRISTINE randomized health services study that aims to compare the effectiveness of negative pressure wound therapy (NPWT) and primary closure (PC) in surgical site infection prevention.\n\nOn admission day, patients will have a Dexcom G6 system placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Patients will be randomized to NPWT or PC according to PRISTINE protocol. Glycemia will be continuously monitored for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* emergency laparotomy for peritonitis\n* written informed consent\n\nExclusion Criteria:\n\n\\- open abdomen treatment'}, 'identificationModule': {'nctId': 'NCT05641792', 'acronym': 'CLUE', 'briefTitle': 'Continuous Glucose Monitoring for Emergency Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Continuous Glucose Monitoring for Emergency Laparotomy', 'orgStudyIdInfo': {'id': '420/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGM pre-, intra- and postoperatively', 'description': 'Patients will have a Dexcom G6 system placed on admission on outer part of the arm, glycaemia will be monitored for 10 consecutive days', 'interventionNames': ['Device: CGM (Dexcom G6)']}], 'interventions': [{'name': 'CGM (Dexcom G6)', 'type': 'DEVICE', 'otherNames': ['continuous glucose monitoring, CGM, Dexcom G6'], 'description': 'Dexcom G6 system consists of a transmitter and sensor that measure interstitial glycaemia every 5 minutes. Measurements are transmitted via Bluetooth to a compatible device, that uploads the data on a virtual drive. This allows for remote real-time glycaemia monitoring on another device.', 'armGroupLabels': ['CGM pre-, intra- and postoperatively']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80952', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'UCC Division of Oncological, Transplant and General Surgery', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Katarzyna M Polomska', 'role': 'CONTACT', 'email': 'k.polomska@gumed.edu.pl', 'phone': '+48794037928'}, {'name': 'Piotr Spychalski, MD, PhD', 'role': 'CONTACT', 'email': 'piotr.spychalski@gumed.edu.pl', 'phone': '+48667843555'}], 'overallOfficials': [{'name': 'Piotr Spychalski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUG Division of General Surgery'}, {'name': 'Katarzyna Polomska', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Gdansk (MUG)'}, {'name': 'Jaroslaw Kobiela, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUG Division of General Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}