Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:24 AM
Study NCT ID:
NCT07373561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000657744', 'term': 'postintensive care syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of PICS at 12 months after ICU admission', 'timeFrame': '12 months after ICU admission', 'description': 'Presence of PICS at 12 months after ICU admission, defined as impairment in at least one of the three domains (physical, cognitive or mental health) measured with validated instruments and pre-specified cut-off values.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of PICS at 3 and 6 months', 'timeFrame': 'Data will be collected at 3 and 6 months post-discharge', 'description': 'The proportion of participants meeting the PICS definition at 3 and 6 months post-discharge, using the same domain criteria as for the 12-month primary outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Intensive Care Syndrome (PICS)', 'Symptom Burden', 'Intensive Care Unit (ICU) Patients']}, 'descriptionModule': {'briefSummary': "The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time.\n\nResearch question\n\n* What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission?\n* How do the components of PICS evolve during the follow-up period (trajectory)?\n* What risk factors are associated with the development of PICS in ICU survivors?\n* Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)?\n\nThe hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Danish ICU-patients admitted to an intensive care unit at any of the participating hospitals in Denmark.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age\n* Admitted to the intensive care unit for ≥48 hours\n* Acutely admitted to the intensive care unit\n\nExclusion Criteria:\n\n* Patients with limited treatment\n* Foreign patients\n* Pregnant women\n* Patient with impaired cognitive function (e.g. dementia, intellectual disability)\n* Patient without Danish citizenship\n* Patient with limited proficiency in the Danish language'}, 'identificationModule': {'nctId': 'NCT07373561', 'acronym': 'PICAS-DK', 'briefTitle': 'Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)', 'orgStudyIdInfo': {'id': 'ID not known yet'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU patients', 'description': 'This study investigates ICU survivor patients in Denmark and aim to estimate the prevalence of post-intensive care syndrome within this group. There are three different follow-up times.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Ph.D, Critical Care Registered Nurse', 'investigatorFullName': 'Camilla Bekker Mortensen', 'investigatorAffiliation': 'Zealand University Hospital'}}}}