Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-02 @ 5:17 PM
Study NCT ID:
NCT02455492
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Perioperative Outcomes in Non-emergency Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266436}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative mortality (yes/no)', 'timeFrame': 'up to 60 days of surgery', 'description': 'all-cause mortality within the specified time frame; both in and out of hospital; as recorded in primary care patient record and validated using Office of National Statistics death certification records; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)'}], 'secondaryOutcomes': [{'measure': 'Acute coronary syndrome (yes/no)', 'timeFrame': 'within 30 days of surgery', 'description': 'physician diagnosed and occurring within the specified time frame; as recorded in patient care record; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)'}, {'measure': 'Pneumonia (yes/no)', 'timeFrame': 'within 30 days of surgery', 'description': 'physician diagnosed and occurring within the specified time frame; as recorded in patient care records; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mortality', 'Perioperative period', 'Elective surgical procedures'], 'conditions': ['Stroke', 'Acute Coronary Syndrome', 'Pneumonia']}, 'descriptionModule': {'briefSummary': 'This epidemiological study investigates the association of recent stroke, acute coronary syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and cardiac surgery using routinely collected UK primary and secondary care patient data.', 'detailedDescription': 'Previous studies have identified prior stroke, heart attack or current diabetes mellitus and anaemia as important risk factors for adverse outcomes following surgery. Recent heart attacks are associated with greater risks than older ones. While recent data suggests that newer strokes impart significantly greater risk than older strokes, there is a lack of concordance on the literature on this, despite the plausibility of the finding. Despite knowledge that prior pneumonia has long-term health risks, there is a lack of data on whether prior pneumonia influences perioperative risk or whether the time interval from pneumonia to surgery affects this relationship. Furthermore while diabetes mellitus and anaemia are known to be important perioperative risk factors, the relationship between haemoglobin concentration or HbA1c levels and perioperative outcomes is unclear. The aim of this epidemiological study is to explore these associations with perioperative risk in the United Kingdom Clinical Practice Research Datalink (with linkage to Hospital Episode Statistics data and Office of National Statistics mortality data).\n\nThe research aims are:\n\n1. To investigate the association between three recent acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.\n2. To investigate the association between time-elapsed between acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.\n3. To investigate numerical risk thresholds for haemoglobin and HbA1c that could predict adverse perioperative outcomes following non-cardiac and cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients within the Clinical Practice Research Datalink who have undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02455492', 'briefTitle': 'Factors Associated With Perioperative Outcomes in Non-emergency Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'An Epidemiological Investigation Into the Association Between Recent Stroke, Acute Coronary Syndrome or Pneumonia and Adverse Perioperative Outcomes Following Elective Non-cardiac and Cardiac Surgery', 'orgStudyIdInfo': {'id': '15_034R'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stroke or myocardial infarction or pneumonia', 'type': 'OTHER', 'description': 'There are three main exposure groups with exposure defined as a binary variable (yes/no): Stroke in the six months prior to surgery; Myocardial infarction in the six months prior to surgery; Pneumonia in the six months prior to surgery'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Puja R Myles, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}