Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 2:33 PM
Study NCT ID:
NCT07038057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolomics changes form', 'timeFrame': 'On the 7th day after enrollment', 'description': 'Key assessments include: ① Concentration changes of differential metabolites in core pathways (BCAA, SCFA, bile acid metabolism); ② Correlation between metabolite fluctuations and nutritional markers (albumin, prealbumin); ③ Predictive modeling linking metabolic signatures to clinical outcomes (infection rate, ICU LOS). The above data were all normalized and ultimately presented in the form of a heatmap.'}], 'secondaryOutcomes': [{'measure': 'Daily average protein intake', 'timeFrame': '7 days', 'description': 'Daily average protein intake, including EN, PN, IVAA, and measurable oral protein supplements; oral diets with unquantifiable protein content excluded (Unit: g).'}, {'measure': 'Daily average energy intake', 'timeFrame': '7 days', 'description': 'Daily average energy intake (Unit: g).'}, {'measure': 'Energy adequacy rate', 'timeFrame': 'On the 3rd and 7th day after enrollment', 'description': 'Energy adequacy rate on the 3rd and 7th day after enrollment (Unit: %).'}, {'measure': 'Inflammatory markers', 'timeFrame': '7 days', 'description': 'Including C-reactive protein (CRP) (Unit: mg/L), White blood cell count (WBC) (Unit: \\*10\\^9/L), and Neutrophil count (Neut#) (Unit: \\*10\\^9/L).'}, {'measure': 'Nutritional status', 'timeFrame': '7 days', 'description': 'Albumin (Alb) (Unit: g/L) and Pre-albumin (PA) (Unit: mg/L).'}, {'measure': 'Liver function', 'timeFrame': '7 days', 'description': 'Bilirubin (BIL) (Unit: μmol/L)'}, {'measure': 'Renal function', 'timeFrame': '7 days', 'description': 'Blood urea nitrogen (BUN) (Unit: mmol/L) and Serum creatinine (Cr) (Unit: umol/L).'}, {'measure': 'Enteral nutritional tolerance rate', 'timeFrame': '7 days', 'description': 'Manifestations of enteral nutrition intolerance:\n\nGastric retention (gastric residual volume \\> 500 mL within 4 hours) Severe nausea or vomiting; Abdominal distension; Diarrhea (≥ 3 bowel movements per day with loose stools, Bristol Stool Scale type 5-7); Hematochezia leading to hemodynamic instability.'}, {'measure': 'Skeletal muscle depletion condition', 'timeFrame': '7 days', 'description': 'A single cross-sectional image at the L3 level was obtained via CT scan. Skeletal muscle was identified and quantified within the image using Hounsfield Unit (HU) thresholds of -29 to +150. The total muscle area at this level was calculated using ImageJ image analysis software. After normalization by the square of height (m²), the third lumbar skeletal muscle index (L3-SMI) was derived.'}, {'measure': 'Days of ventilator use', 'timeFrame': '28 days'}, {'measure': '28-day all-cause mortality rate', 'timeFrame': '28 days'}, {'measure': 'All-cause mortality at 90 days', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.', 'detailedDescription': 'This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.\n\nShort-peptide formula group:\n\nWithin 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.\n\nWhole-protein formula group:\n\nWithin 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.\n\nThe study will assess changes in metabolomics after 7 days of early enteral nutrition with different protein formulations in sepsis patients, as well as differences in nutritional status, biochemical markers, and short- and long-term clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent has been signed\n2. Aged from 18 to 80 years old\n3. Within 24 hours after admission to ICU\n4. Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria\n5. Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition\n6. Expected ICU stay for more than 7 days\n\nExclusion Criteria:\n\n1. Receiving palliative care or expected to die within 72 hours\n2. Pregnant or breastfeeding\n3. Use of high dose vasopressor maintenance (norepinephrine dosage \\> 0.5 μg/kg/min)\n4. Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)'}, 'identificationModule': {'nctId': 'NCT07038057', 'briefTitle': 'Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'B2025-213R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short peptide formula', 'description': 'Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.', 'interventionNames': ['Dietary Supplement: Short peptide enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole protein formula', 'description': 'Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.', 'interventionNames': ['Dietary Supplement: Whole protein enteral nutrition']}], 'interventions': [{'name': 'Short peptide enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Short peptide formula enteral nutrition was initiated within 48 hours after admission to the ICU. For patients with poor swallowing function or no consciousness, nasogastric tubes were placed. Starting from low-calorie or nourishing feeding, 70% of the target energy should be achieved within 7 days, and the protein should be 1.2-1.5 g/kg/d. Due to the large individual differences in energy expenditure among patients with sepsis, the indirect calorimetry (IC) method was used to determine energy expenditure. If the IC method is not feasible, the calculation formula based on body weight: 20-25 kcal/kg/d should be applied for calculation. If the patient is not transferred out of the ICU after 7 days, continue to gradually increase to the target energy and protein requirements under tolerable conditions, and gradually transition to whole protein nutrition after 7 days.', 'armGroupLabels': ['Short peptide formula']}, {'name': 'Whole protein enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.', 'armGroupLabels': ['Whole protein formula']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yanni Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'yanni99@126.com', 'phone': '+86 13381819621'}, {'name': 'JieQiong Song, MD, PhD', 'role': 'CONTACT', 'email': 'song.jieqiong@zs-hospital.sh.cn', 'phone': '+86 13917056745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ming Zhong', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}