Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05026151
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2021-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017674', 'term': 'Hypophosphatemia'}, {'id': 'D055677', 'term': 'Refeeding Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-02', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy balance', 'timeFrame': 'up to 30 days', 'description': 'Delta between energy delivery and prescription'}], 'secondaryOutcomes': [{'measure': 'Feeding route and time to feeding', 'timeFrame': 'up to 30 days', 'description': 'Proportion of days on enteral, parenteral, combined, oral feeding or fasting'}, {'measure': 'Hypophosphataemia', 'timeFrame': 'up to 30 days', 'description': 'Number of blood phosphate values \\<0.8 mmol/l'}, {'measure': 'Insulin resistance', 'timeFrame': 'up to 30 days', 'description': 'Quantity of insulin required to maintain blood glucose with ICU targets'}, {'measure': 'Bowel activity', 'timeFrame': 'up to 30 days', 'description': 'Frequency of diarrhea and constipation'}, {'measure': 'Length of ICU and hospital stay', 'timeFrame': 'up to 3 months', 'description': 'length in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical care', 'Metabolism', 'Nutrition', 'Propofol sedation', 'Hypophosphatemia', 'Refeeding syndrome', 'Insulin resistance', 'Malnutrition'], 'conditions': ['Persistent Critical Illness']}, 'descriptionModule': {'briefSummary': 'The Corona Virus Disease-19 (COVID-19) pandemic has resulted in an overwhelming number of intensive care (ICU) patient admissions, generally for acute respiratory distress, often resulting in persistent critical illness (PCI). Little is known about their metabolic and nutritional characteristics compared to other non-COVID (non-CO) categories of patients.\n\nThe aim is to compare the metabolic characteristics and gastro-intestinal function of the previously admitted non-CO and COVID persistent critically ill patients, and the adherence to the ICU nutrition protocol.\n\nProspective observation study including two consecutive cohorts of PCI, defined by a prolonged mechanical ventilation requirement longer than 10days.', 'detailedDescription': 'The metabolic and nutritional characteristics of the COVID-19 patients requiring prolonged ICU treatment compared to other non-COVID (non-CO) categories of patients remain poorly described. The aim was to compare the metabolic characteristics of the previously admitted non-CO and COVID PCI patients.\n\nProspective observation study including two consecutive cohorts of PCI, defined as requiring a mechanical ventilation for \\>10 days.\n\nThe comparative cohort is the first patient cohort previously registered as NCT03938961.\n\nVariables: demographic data, severity score (SAPS2, organ failure (SOFA) scores), Nutrition Risk Screening (NRS) score, C-reactive protein (CRP), blood phosphate. Nutritional variables: energy intake (detail of protein, lipids, glucose), fasting time, feeding route, prealbumin values, bowel activity, insulin requirements Outcome: length of mechanical ventilation, ICU and hospital stay and outcome. Descriptive statistics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients requiring prolonged ICU treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients requiring more than 10 days on mechanical ventilation\n\nExclusion Criteria:\n\n* patients refusing use of their coded data\n* admission for brain injury or after cardiac arrest\n* admission for major burns \\>20% body surface area (BSA)'}, 'identificationModule': {'nctId': 'NCT05026151', 'acronym': 'MetaCO-nonCO', 'briefTitle': 'Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Comparing Metabolic and Nutrition Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients', 'orgStudyIdInfo': {'id': 'CER2020-01453'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-CO', 'description': 'Consecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave', 'interventionNames': ['Other: Nutrition therapy according to ICU protocol']}, {'label': 'COVID', 'description': 'Consecutive persistent critically ill COVID-19 patients requiring more than 10 days of mechanical ventilation, admitted during the first COVID-19 wave', 'interventionNames': ['Other: Nutrition therapy according to ICU protocol']}], 'interventions': [{'name': 'Nutrition therapy according to ICU protocol', 'type': 'OTHER', 'description': 'The study aims a verifying adherence to the ICU nutrition protocol', 'armGroupLabels': ['COVID', 'non-CO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Lausanne University Hospital - CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Philippe Eckert, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Lausanne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Emeritus, Research Staf, Adult Intensive Care Department', 'investigatorFullName': 'Mette M Berger', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}