Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-07 @ 9:51 PM
Study NCT ID:
NCT05679661
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2022-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093702', 'term': 'Immunonutrition Diet'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pulmonary complications', 'timeFrame': 'within 7 days after surgery', 'description': 'evaluated by trained investigator'}], 'secondaryOutcomes': [{'measure': 'postoperative pneumonia', 'timeFrame': 'within 7 days after surgery', 'description': 'defined according to the US Centers for Disease Control Definition'}, {'measure': 'postoperative recovery', 'timeFrame': 'within 30 days after surgery', 'description': 'evaluated by QoR-15 and WHODAS2.0'}, {'measure': 'Comprehensive complication index (CCI)', 'timeFrame': 'within 30 days after surgery', 'description': 'postoperative complication evaluated using Comprehensive complication index'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From date of surgery until discharge day, assessed up to 4 weeks', 'description': 'Postoperative length of hospital stay assessed by days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.', 'detailedDescription': 'This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age≥65 years;\n2. undergoing non-cardiac surgery (expected duration \\>2 hours);\n3. scheduled for general anesthesia and endotracheal intubation;\n4. ASA classification I-IV;\n5. with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);\n6. inform consent obtained\n\nExclusion Criteria:\n\n1. emergency surgery;\n2. preoperative pneumonia;\n3. allergic to chlorhexidine;\n4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;\n5. expected intervention of immunonutrition\\<3 days.'}, 'identificationModule': {'nctId': 'NCT05679661', 'briefTitle': 'Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'K2870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)', 'description': 'Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.', 'interventionNames': ['Dietary Supplement: immunonutrition', 'Behavioral: oral chlorhexidine decontamination']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (immunonutrition and routine oral care, IN&RC)', 'description': 'Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care.', 'interventionNames': ['Dietary Supplement: immunonutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)', 'description': 'Patients will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.', 'interventionNames': ['Behavioral: oral chlorhexidine decontamination']}, {'type': 'NO_INTERVENTION', 'label': 'Group D (routine nutrition advice and routine oral care, RN&RC)', 'description': 'Patients will be advised to follow a standard nutrition advice and routine oral care.'}], 'interventions': [{'name': 'immunonutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.', 'armGroupLabels': ['Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)', 'Group B (immunonutrition and routine oral care, IN&RC)']}, {'name': 'oral chlorhexidine decontamination', 'type': 'BEHAVIORAL', 'description': 'Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.', 'armGroupLabels': ['Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)', 'Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Che, M.D', 'role': 'CONTACT', 'email': 'tracymaobao@126.com'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lu Che, MD', 'role': 'CONTACT', 'email': 'tracymaobao@126.com', 'phone': '69152020'}, {'name': 'Jiawen Yu, MD', 'role': 'CONTACT', 'email': 'jiawen_yu@foxmail.com', 'phone': '69152020'}], 'overallOfficials': [{'name': 'Yuguang Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital (CAMS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huang YuGuang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huang YuGuang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}