Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT00463333
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2005-09-10', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative delirium', 'psychometric testing', 'EEG', 'serum markers'], 'conditions': ['Postoperative Delirium']}, 'referencesModule': {'references': [{'pmid': '21037129', 'type': 'DERIVED', 'citation': 'Plaschke K, Kopitz J, Mattern J, Martin E, Teschendorf P. Increased cortisol levels and anticholinergic activity in cognitively unimpaired patients. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):433-41. doi: 10.1176/jnp.2010.22.4.433.'}]}, 'descriptionModule': {'briefSummary': "Summary:\n\nPostoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients at Intensive Care Unit over a defined time period\n* Over 18 years old\n\nExclusion Criteria:\n\n* Elective heart and vascular patients'}, 'identificationModule': {'nctId': 'NCT00463333', 'briefTitle': "Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers", 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'orgStudyIdInfo': {'id': '196/2004'}}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Heidelberg', 'country': 'Germany', 'facility': 'Intensive Care Unit, Clinic of Anesthesiology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Markus A Weigand, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Faculty, Clinic of Anesthesiology, University of Heidelberg'}, {'name': 'Konstanze Plaschke, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Else Kröner Fresenius Foundation', 'class': 'OTHER'}]}}}