Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT01437358
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2011-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-27', 'studyFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2011-09-19', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of epidural analgesia-related complications', 'timeFrame': 'up to 1 month'}]}, 'conditionsModule': {'keywords': ['Epidural catheter', 'Epidural analgesia', 'Intensive care unit', 'Safety'], 'conditions': ['Critical Illness', 'Epidural Analgesia']}, 'referencesModule': {'references': [{'pmid': '26004880', 'type': 'DERIVED', 'citation': 'Jabaudon M, Chabanne R, Sossou A, Bertrand PM, Kauffmann S, Chartier C, Guerin R, Imhoff E, Zanre L, Brenas F, Bazin JE, Constantin JM. Epidural analgesia in the intensive care unit: An observational series of 121 patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):217-23. doi: 10.1016/j.accpm.2014.12.002. Epub 2015 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients.', 'detailedDescription': 'BACKGROUND:\n\nEpidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking.\n\nDESIGN NARRATIVE:\n\nThis observational multicenter prospective clinical study will report the incidence of EA-related complications, such as infectious or neurologic complications, and the mean duration of EA in the ICU settings.\n\nPatients admitted in three intensive care units (two from an University Hospital and one from a local hospital) and receiving EA will be included in the study, whether the EA catheter is inserted in the ICU or outside the ICU, e.g. in the operating room. Demographics, clinical and biological data will be recorded prospectively. The main goal is to evaluate the safety and feasibility of EA in critically ill patients, being assumed this technique is currently and routinely used in our intensive care units, in accordance with national and international guidelines on epidural analgesia practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room.\n\nExclusion Criteria:\n\n* none (besides classic contra-indications for epidural analgesia catheter insertion, e.g. coagulation disorder, local infection…)'}, 'identificationModule': {'nctId': 'NCT01437358', 'briefTitle': 'Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study', 'orgStudyIdInfo': {'id': 'CHU-0100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intensive care unit', 'interventionNames': ['Other: Epidural analgesia']}], 'interventions': [{'name': 'Epidural analgesia', 'type': 'OTHER', 'description': 'The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients', 'armGroupLabels': ['intensive care unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Mathieu JABAUDON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}, {'name': 'Jean-Michel CONSTANTIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}, {'name': 'Russel CHABANNE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}, {'name': 'Bernard CLAUD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}