Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 12:40 AM
Study NCT ID:
NCT02914756
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HMGB1 in ICU-survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?', 'timeFrame': '2 years'}, {'measure': 'Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '33725363', 'type': 'DERIVED', 'citation': 'Bruck E, Svensson-Raskh A, Larsson JW, Caravaca AS, Gallina AL, Eberhardson M, Sackey PV, Olofsson PS. Plasma HMGB1 levels and physical performance in ICU survivors. Acta Anaesthesiol Scand. 2021 Aug;65(7):921-927. doi: 10.1111/aas.13815. Epub 2021 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being treated at Karolinska University Hospital Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female age 18-17\n* Expected ICU-stay more than 24 hours\n\nExclusion Criteria:\n\n* Dont understand the language\n* Substance abuse, alcohol or drugs\n* Blind, deaf or suffering from aphasia\n* Ongoing psychiatric illness or psychopharmacological treatment\n* Suffering from dementia och mentally impaired\n* Structured brain damage or meningitis\n* Palliative Care\n* ICU-treated for more than 48 hours\n* Transferred from other ICU\n* Being treated with ECMO\n* Not having residency in Stockholm'}, 'identificationModule': {'nctId': 'NCT02914756', 'briefTitle': 'HMGB1 in ICU-survivors', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation', 'orgStudyIdInfo': {'id': 'EPN 2013/1221-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'description': 'Patients suffering from Severe sepsis or Septic chock at the ICU.'}, {'label': 'Non-Sepsis', 'description': 'Patients being treated at ICU but not suffering from severe sepsis/septic chock'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Peter Sackey', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}