Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-04-15 @ 1:58 PM
Study NCT ID:
NCT06576895
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Practice in Critically Ill Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Protein and energy prescription and provision'}, {'measure': 'Nutritional outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Use of Enteral Nutrition (EN)'}, {'measure': 'Nutritional outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Parenteral Nutrition (PN)'}, {'measure': 'Nutritional outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Oral intake and oral nutrition supplements'}, {'measure': 'Nutrition service delivery in the ICU and ward setting', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Levels of staffing available and service provision for nutrition care in the ICU and on the ward'}, {'measure': 'Descriptions of nutrition prescription, delivery and service variability across ANZ', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Comparison of nutrition care between participating hospitals'}, {'measure': 'Patient-centred outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Duration of hospital stay'}, {'measure': 'Patient-centred outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Mortality'}, {'measure': 'Patient-centred outcomes', 'timeFrame': 'Up to day 28 of hospitalization', 'description': 'Discharge destination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care', 'Nutrition'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing.\n\nThe aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.', 'detailedDescription': 'This study is a multi-centre observational study of nutrition practices in critically ill adults across ANZ. Two study periods are proposed, the first confirmed period in Q3-2024 and the second in 2026.\n\nThis study is part of a larger study which consists of three interconnected streams. This study forms part of Stream 2 which is about understanding nutrition practice and provision in adults with critical illness. The findings from this study will be used to inform the development and implementation of new models of nutrition care for adults with critical illness.\n\nOn the day of study commencement (day 1), all patients treated in the ICU and admitted to the ICU after 00:00 will be screened for eligibility. Observational data will be collected days 1 and 3 of their ICU stay (whilst present in ICU) and then days 7, 14, 21 and 28 (whether they are in ICU or the ward) as well as the first full day on the ward (day after ICU discharge).\n\nAt the completion of the project, the investigators will hold the largest sample of nutrition care in critical illness in Australia (approximately 1200 Adult patients including the pilot data period) and the only international database to include the period after ICU discharge. This proposal directly links with the National Safety and Quality Health Service (NSQHS) Standard 5 (Comprehensive Care) and Standard 2 (Partnering with Consumers) and will rapidly provide data about nutrition care and hospital acquired malnutrition (a serious reportable consequence under Standard 5) to inform the accreditation process and provide a risk mitigation strategy to prevent malnutrition before it occurs. This data will be used to improve and re-design nutrition care, as well as generate new research priorities that are highly relevant to issues within clinical care, with the potential to save millions of dollars in healthcare expenditure nationally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In a 7 day study period, all adult patients present in the ICU who meet all of the inclusion criteria and no exclusion criteria will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Admitted to ICU after 00:00 on the date of study commencement\n3. Remain in ICU for ≥ 48 hours\n\nExclusion Criteria:\n\n1. Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g., due to bed unavailability, inability to return home)\n2. Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission'}, 'identificationModule': {'nctId': 'NCT06576895', 'acronym': 'NUTRIENT', 'briefTitle': 'Nutrition Practice in Critically Ill Adults', 'organization': {'class': 'OTHER', 'fullName': 'Australian and New Zealand Intensive Care Research Centre'}, 'officialTitle': 'Nutrition Practice in Critically Ill Adults - an Observational Study', 'orgStudyIdInfo': {'id': 'ANZIC-RC/ER002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tina van Tonder', 'role': 'CONTACT', 'email': 'nutrient@monash.edu'}], 'facility': 'Monash University', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Emma Ridley, A/Prof', 'role': 'CONTACT', 'email': 'nutrient@monash.edu', 'phone': '+61 3 9903 0350'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australian and New Zealand Intensive Care Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}