Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 5:24 AM
Study NCT ID:
NCT04128735
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of diastolic dysfunction', 'timeFrame': 'during surgery', 'description': 'Prevalence of diastolic dysfunction according to American society of echocardiography definition'}], 'secondaryOutcomes': [{'measure': 'Prevalence of other cardiac abnormalities', 'timeFrame': 'during surgery', 'description': 'Number of patients with other cardiac abnormalities, both structural and functional abnormalities'}, {'measure': 'Incidence of cardiac adverse events', 'timeFrame': 'within 24 hours after surgery', 'description': 'Number of patients with cardiac adverse event: myocardial ischemia, pulmonary edema'}, {'measure': 'Incidence of pulmonary adverse events', 'timeFrame': 'within 24 hours after surgery', 'description': 'Number of patients experienced aspiration, desaturation, re-intubation'}, {'measure': 'Incidence of oral and airway trauma', 'timeFrame': 'within 24 hours after surgery', 'description': 'Number of patients with new loose teeth, sore throat, difficult to swallow, hoarseness of voice'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 5 days', 'description': 'duration of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diastolic dysfunction', 'Morbid Obesity', 'Bariatric surgery'], 'conditions': ['Diastolic Dysfunction', 'Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '22699700', 'type': 'BACKGROUND', 'citation': "Cabrera Schulmeyer MC, Arriaza N. Good prognostic value of the intraoperative tissue Doppler-derived index E/e' after non-cardiac surgery. Minerva Anestesiol. 2012 Sep;78(9):1013-8. Epub 2012 Jun 14."}, {'pmid': '23998692', 'type': 'BACKGROUND', 'citation': 'Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available.'}, {'pmid': '22261198', 'type': 'RESULT', 'citation': 'Aljaroudi W, Alraies MC, Halley C, Rodriguez L, Grimm RA, Thomas JD, Jaber WA. Impact of progression of diastolic dysfunction on mortality in patients with normal ejection fraction. Circulation. 2012 Feb 14;125(6):782-8. doi: 10.1161/CIRCULATIONAHA.111.066423. Epub 2012 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.', 'detailedDescription': 'Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities. Many cardiac problems were previously reported including left ventricular hypertrophy, right and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in normal left ventricular systolic function and can lead to diastolic heart failure postoperatively.\n\nPreoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this problem may be underestimated. Transesophageal echocardiogram provides better cardiac view, but requires sedation during procedure. So, it is not practical for out-patient setting. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Criteria for patient enrolled to bariatric surgery in Siriraj hospital\n\n* BMI more than 40 kg/m2\n* BMI more than 35 kg/m2 with hypertension, type 2 diabetes, hyperlipidemia, obstructive sleep apnea, chronic arthritis\n* age between 18 - 70 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient scheduled for bariatric surgery in Siriraj hospital\n\nExclusion Criteria:\n\n* Patient refusal\n* patient with contraindication for transesophageal echocardiogram such as preexisting esophageal disease, recent upper gastrointestinal bleeding, coagulopathy, etc. (according to American society of Echocardiography guideline)'}, 'identificationModule': {'nctId': 'NCT04128735', 'briefTitle': 'Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery', 'orgStudyIdInfo': {'id': '2018_2'}}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Aphichat Suphathamwit, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}