Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440161
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-06
Brief Title:
Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Association of Intraoperative Haemodynamic Instability With Postoperative Mortality Renal Injury and Stroke in Type A Aortic Dissection Surgery A Retrospective Cohort Analysis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection TAAD
Methods 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
Methods 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
Detailed Description:
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
Preoperatively 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 5127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKIAKD risk determinants However the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKIAKD remains elusive Theres 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 AKIAKD 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
Preoperatively 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 5127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKIAKD risk determinants However the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKIAKD remains elusive Theres 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 AKIAKD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None