Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06065202
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2023-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Nutrition to Improve Recovery in Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000007', 'term': 'Abdominal Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in six-minute walk distance (6 MWD)', 'timeFrame': '3 months', 'description': 'Change in 6MWD from baseline to day 14 or hospital discharge will be compared between the two study arms'}], 'secondaryOutcomes': [{'measure': 'Change in physical function', 'timeFrame': 'baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by comparing the changes in physical function tests (4 meter walk, sit-to-stand) between the two study arms.'}, {'measure': 'Change in muscle strength', 'timeFrame': 'baseline, hospital discharge, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by comparing the changes in grip and quad strength tests between the two study arms.'}, {'measure': 'Change in muscle mass', 'timeFrame': 'baseline, hospital discharge, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by comparing changes in bioelectrical impedance analysis (BIA) between the two study arms.'}, {'measure': 'Change in Quality of Life (QoL)', 'timeFrame': 'baseline, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by comparing changes in the EuroQoL-5 Dimension and 43-item Trauma Specific Quality of Life measurement between the two study arms.'}, {'measure': 'Change in cognition', 'timeFrame': 'baseline, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by looking at changes in mental health and cognition via questionnaires.'}, {'measure': 'Infection', 'timeFrame': 'hospital discharge, 3 and 6 months post-hospital discharge', 'description': 'This will be measured by looking at the number of infections reported.'}, {'measure': 'Length of Hospital/ICU stay', 'timeFrame': 'hospital discharge', 'description': 'This will be measured by recording the length of hospital stay noted in the medical record.'}, {'measure': 'Mortality rate', 'timeFrame': '6 months post-hospital discharge', 'description': 'This will be measured by survival after 6 months.'}, {'measure': 'Change in muscle mitochondrial metabolism', 'timeFrame': 'admission, day 14, and hospital discharge', 'description': 'This will be measured by doing urine and blood tests.'}, {'measure': 'Change in key resilience and inflammation biomarkers', 'timeFrame': 'admission, day 14, and hospital discharge', 'description': 'This will be measured utilizing the Duke Pepper Panel which serves as a comprehensive set of biological indicators typically incorporating: hormones, inflammatory markers and genomic factors.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['precision nutrition', 'critical care', 'trauma', 'parenteral nutrition', 'indirect calorimetry'], 'conditions': ['Abdominal Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.', 'detailedDescription': 'Severe abdominal trauma can impact patients in a variety of ways. Current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (IV) nutrition will improve outcomes. Participants will be randomly assigned 1:1, like flipping a coin, to the SeND Home program or routine care.\n\nParticipants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. This may include TPN.\n\nParticipants in the SeND Home program will receive TPN within 72 hours of abdominal surgery. Indirect calorimetry will be used to determine nutrition needs.Once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge.\n\nParticipants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15+ years old\n* Penetrating abdominal trauma requiring emergent major abdominal surgery\n* Admitted to the surgical ICU\n* Not expected to receive oral nutrition for 72 hours or more\n\nExclusion Criteria:\n\n* Patients who are unable to ambulate at baseline\n* Expected withdrawal of life-sustaining treatment within 48 hours\n* Prisoners\n* Positive pregnancy test for women of child bearing potential.'}, 'identificationModule': {'nctId': 'NCT06065202', 'acronym': 'SeND Home', 'briefTitle': 'Personalized Nutrition to Improve Recovery in Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma', 'orgStudyIdInfo': {'id': 'Pro00112343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SeND Home Pathway', 'description': 'Total parenteral nutrition (TPN) will begin within 72 hours of abdominal surgery. Calorie needs will be determined by indirect calorimetry. Nutritional shakes will begin when a liquid diet is started. These will be taken 3 times a day while in the hospital and for 4 weeks after discharge.', 'interventionNames': ['Dietary Supplement: Nutrition Supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Nutrition', 'description': 'Standard nutrition as determined by clinical providers.'}], 'interventions': [{'name': 'Nutrition Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CLINIMIX E 8/14 sulfite-free', 'CLINOLIPID 20%', 'Nutritional shakes'], 'description': 'Total parenteral nutrition (TPN) will be administered within 72 hours of abdominal surgery. Nutritional shakes will be started with a liquid diet and given 3 times a day. This will continue for 4 weeks after discharge.', 'armGroupLabels': ['SeND Home Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shauna Howell', 'role': 'CONTACT', 'email': 'shauna.eggertson@duke.edu', 'phone': '919-668-3771'}, {'name': 'Krista Haines, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Krista Haines, MD', 'role': 'CONTACT', 'email': 'krista.haines@duke.edu', 'phone': '919-681-3784'}, {'name': 'Hilary Winthrop', 'role': 'CONTACT', 'email': 'hilary.winthrop@duke.edu', 'phone': '919-668-7238'}], 'overallOfficials': [{'name': 'Paul Wischmeyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}