Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
Study NCT ID:
NCT03777150
Status:
UNKNOWN
Last Update Posted:
2018-12-17
First Post:
2018-12-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011182', 'term': 'Postoperative Care'}, {'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total length of hospital stay', 'timeFrame': 'From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months', 'description': "The total length of patient's hospital stay will be recorded"}], 'secondaryOutcomes': [{'measure': 'Preoperative length of hospital stay', 'timeFrame': 'From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months', 'description': "The preoperative length of patient's hospital stay will be recorded"}, {'measure': 'Postoperative length of hospital stay', 'timeFrame': 'From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months', 'description': "The postoperative length of patient's hospital stay will be recorded"}, {'measure': 'Postoperative complications', 'timeFrame': 'From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months', 'description': 'All postoperative complications will be recorded'}, {'measure': "Patient's outcome at 28 days postoperatively", 'timeFrame': 'From the first postoperative day until 28 days postoperatively', 'description': '28 day postoperative mortality will be recorded'}, {'measure': 'Total cost of hospital care', 'timeFrame': 'From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months', 'description': 'The total cost of hospital care will be recorded for every patient'}, {'measure': 'Postoperative cost of hospital care', 'timeFrame': 'From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months', 'description': 'The postoperative cost of hospital care will be recorded for every patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care', 'postoperative care', 'elective surgery'], 'conditions': ['Postoperative Care', 'Intensive Care']}, 'descriptionModule': {'briefSummary': "Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.", 'detailedDescription': 'A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk\n\nExclusion Criteria:\n\n* Patients that are operated on an emergency basis'}, 'identificationModule': {'nctId': 'NCT03777150', 'briefTitle': 'Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?', 'organization': {'class': 'OTHER', 'fullName': 'Saint Savvas Anticancer Hospital'}, 'officialTitle': "Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?", 'orgStudyIdInfo': {'id': 'ICU postoperative care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group ICU', 'description': 'Group ICU:patients are admitted directly into the ICU for postoperative care', 'interventionNames': ['Other: Postoperative care in Intensive care unit (ICU)']}, {'type': 'EXPERIMENTAL', 'label': 'Group Ward', 'description': 'Group Ward:patients are admitted directly into the standard ward for postoperative care', 'interventionNames': ['Other: Postoperative care in standard ward']}], 'interventions': [{'name': 'Postoperative care in Intensive care unit (ICU)', 'type': 'OTHER', 'description': 'Postoperative care in Intensive care unit (ICU)', 'armGroupLabels': ['Group ICU']}, {'name': 'Postoperative care in standard ward', 'type': 'OTHER', 'description': 'Postoperative care in standard ward', 'armGroupLabels': ['Group Ward']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Georgia Micha, MD, MSc, PhD', 'role': 'CONTACT', 'phone': '+306974828254'}], 'facility': 'Saint Savvas Anticancer Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Georgia Micha, MD, PhD', 'role': 'CONTACT', 'email': 'mgeo3@yahoo.gr', 'phone': '6974828254', 'phoneExt': '0030'}, {'name': 'Vasiliki Chantziara, MD, PHD', 'role': 'CONTACT', 'email': 'vchantziara@yahoo.gr', 'phone': '6937173376', 'phoneExt': '0030'}], 'overallOfficials': [{'name': 'Anna Efthimiou, Head of the department', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saint Savvas Anticancer hospital of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Savvas Anticancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist,MD, PhD Principal Investigator', 'investigatorFullName': 'Georgia Micha', 'investigatorAffiliation': 'Saint Savvas Anticancer Hospital'}}}}