Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-04 @ 4:02 PM
Study NCT ID:
NCT00466492
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2007-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588663', 'term': 'Wake protein, Drosophila'}, {'id': 'D003422', 'term': 'Critical Care'}, {'id': 'C071130', 'term': 'hemoglobin Denmark Hill'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-18', 'studyFirstSubmitDate': '2007-04-26', 'studyFirstSubmitQcDate': '2007-04-26', 'lastUpdatePostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time receiving mechanical ventilation, total intensive care and hospital length of stay.'}], 'secondaryOutcomes': [{'measure': 'The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses', 'timeFrame': 'VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Administration Schedule', 'Intensive Care Units', 'Length of Stay', 'Respiration, Artificial', 'Stress Disorders, Post-Traumatic/etiology/*psychology', 'Critical Illness/*psychology', 'Pneumonia/prevention & control', 'Hypnotics and Sedatives/*administration & dosage'], 'conditions': ['Critical Illness', 'Length of Stay', 'Respiration, Artificial', 'Intensive Care Units']}, 'referencesModule': {'references': [{'pmid': '10816184', 'type': 'RESULT', 'citation': "Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002."}, {'pmid': '14525802', 'type': 'RESULT', 'citation': 'Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.'}, {'pmid': '15187505', 'type': 'RESULT', 'citation': 'Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.'}, {'pmid': '22166673', 'type': 'DERIVED', 'citation': 'Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.'}, {'pmid': '21542927', 'type': 'DERIVED', 'citation': 'Strom T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. doi: 10.1186/cc10218. Epub 2011 May 4.'}, {'pmid': '20116842', 'type': 'DERIVED', 'citation': 'Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.'}], 'seeAlsoLinks': [{'url': 'http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)62072-9/abstract', 'label': 'Link to the published paper'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.', 'detailedDescription': 'The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.\n\nWe would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.\n\nWe also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated receiving mechanical ventilation\n* Expected to remain intubated more than 24 hours\n* Over 18 years\n\nExclusion Criteria:\n\n* Raised intracranial pressure\n* Pregnant\n* Treatment with muscle relaxants'}, 'identificationModule': {'nctId': 'NCT00466492', 'briefTitle': 'Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Advantages and Disadvantages of Long Term Sedation in ICU Patients', 'orgStudyIdInfo': {'id': '22-6-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No sedatation intervention', 'description': 'The intervention group is the normal care in our institution, the control group is the golden standard', 'interventionNames': ['Procedure: Sedation or no sedation during mechanical ventilation']}], 'interventions': [{'name': 'Sedation or no sedation during mechanical ventilation', 'type': 'PROCEDURE', 'otherNames': ['Awake', 'intensive care', 'Denmark', 'Mechanical ventilation'], 'description': 'No sedation to critically ill patients', 'armGroupLabels': ['No sedatation intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense C', 'state': 'Odense C', 'country': 'Denmark', 'facility': 'Anaesthesiologic-intensive Care Department, Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Palle Toft, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thomas Strøm', 'oldOrganization': 'Anaesthesiologic-intensive unit, Odens University Hospital'}}}}