Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-01 @ 9:00 AM
Study NCT ID:
NCT06440161
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006940', 'term': 'Hyperemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034588', 'term': 'COP protocol 2'}, {'id': 'D062186', 'term': 'Arterial Pressure'}], 'ancestors': [{'id': 'D001794', 'term': 'Blood Pressure'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 543}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of AKI', 'timeFrame': 'After the surgery，up to 7 days', 'description': 'AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria.'}, {'measure': 'The Incidence of AKD', 'timeFrame': 'After the surgery，longer than 7 days but within 90 days', 'description': 'AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery.'}], 'secondaryOutcomes': [{'measure': 'The days of stay in hospital', 'timeFrame': 'perioperatively', 'description': 'The days of stay in hospital'}, {'measure': 'The days of stay in ICU', 'timeFrame': 'after surgery', 'description': 'The days of stay in ICU'}, {'measure': 'The incidence of in-hospital mortality', 'timeFrame': 'after surgery', 'description': 'The incidence of in-hospital mortality'}, {'measure': 'The incidence of 30-day all-cause mortality', 'timeFrame': 'after surgery', 'description': 'The incidence of 30-day all-cause mortality'}, {'measure': 'The incidence of stroke', 'timeFrame': 'after surgery', 'description': 'Stroke diagnosis adhered to National Institute of Neurological Disorders and Stroke rt PA Stroke study Group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Intraoperative Hypotension', 'Venous Congestion', 'Acute Kidney Disease', 'Type A Aortic Dissection'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD).\n\nMethods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons.', 'detailedDescription': "Type A aortic dissection (TAAD) is a catastrophic cardiac macrovascular disease with a striking in-hospital mortality rate of 22%-31%. Among the myriad of complications following TAAD surgeries, acute kidney injury (AKI) is one of the most prevalent, boasting an incidence of 40-55%. Notably, this incidence surpasses that observed in other cardiovascular procedures, such as coronary artery bypass grafting (CABG), which ranges from 10-20%, and aortic valve replacement (AVR) at 17-23%. Furthermore, the occurrence of AKI post-TAAD surgeries has been linked with escalated in-hospital, short-term, and long-term mortalities, as well as significant complications.\n\nPreoperatively, patients with TAAD usually have poorly controlled blood pressure, long-term hypertension can cause chronic kidney damage. In some cases, involving renal artery origins, renal perfusion insufficiency may exist preoperatively. Intraoperatively, the kidneys need to undergo a complete ischemic phase of deep hypothermic circulatory arrest (DHCA), inflammatory reactions associated with cardiopulmonary bypass (CPB), and a large number of blood and fluid transfusions could potentially cause renal dysfunction. Patients are at high risk for postoperative surgical site infection following TAAD procedure, further exacerbating acute kidney injury. The myriad factors mentioned above collectively exacerbate the elevated occurrence of kidney injury following Type A Aortic Dissection (TAAD) surgeries when juxtaposed with other cardiac surgical procedures. Pathological anatomy and surgical procedure intricacies pose formidable challenges in mitigation. Consequently, the pursuit of precise intraoperative hemodynamic management objectives aimed at maximizing organ perfusion has emerged as a focal point in contemporary research endeavours. A study encompassing 5,127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKI/AKD risk determinants. However, the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKI/AKD remains elusive. There's a paucity of comprehensive evaluations, primarily due to a dearth of long-term data from expansive TAAD cohorts. The investigators' primary objective was to discern the correlation between intraoperative hypotension and venous congestion durations and magnitudes at varied thresholds during TAAD surgeries and the subsequent risks of postoperative AKI/AKD. As a secondary objective, the investigators sought to elucidate the association between intraoperative hemodynamic and major adverse events, including stroke and mortality. The investigators hypothesize that both intraoperative hypotension and venous congestion are paramount predictors for postoperative AKI and AKD following TAAD surgeries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients underwent surgery for TAAD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Eligible patients were adults, aged 18 or older.\n\nExclusion Criteria:\n\n1. Lacking preoperative serum creatinine (Scr) values\n2. Insufficient hemodynamic or laboratory data\n3. Exhibiting a preoperative Scr level ≥133 μmol/L\n4. Patients with renal insufficiency before surgery\n5. Patients on preoperative dialysis'}, 'identificationModule': {'nctId': 'NCT06440161', 'briefTitle': 'Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Association of Intraoperative Haemodynamic Instability With Postoperative Mortality, Renal Injury, and Stroke in Type A Aortic Dissection Surgery: A Retrospective Cohort Analysis', 'orgStudyIdInfo': {'id': 'KY20230918-KS-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP).', 'type': 'OTHER', 'description': 'After the induction of anaesthesia, a central venous or pulmonary artery catheter was positioned. Based on prior studies, thresholds for central venous pressure were set at 10, 12, 16, and 20 mm Hg. Venous congestion was quantified by time exceeding each CVP threshold and the area under the curve (AUC) surpassing each CVP threshold in mmHg × min. Assessments were limited to pre- and post-CPB periods, as the venous drainage cannulate generated negative CVP during CPB.\n\nAn arterial catheter was installed upon room admission. Continuous arterial blood pressure monitoring commenced after exposure to atmospheric pressure and calibration to zero. The MAP was determined using the formula: 2/3 × diastolic blood pressure + 1/3 × systolic blood pressure. Data were logged by automated software every minute. Established thresholds for MAP were 55, 65, and 75 mm Hg. Hypotension was quantified as (1) time under each MAP threshold in minutes and (2) the AUC below each MAP threshold in mmHg × min.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ya-li Ge', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}