Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-30 @ 8:48 PM
Study NCT ID:
NCT06775158
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2025-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection
Sponsor:
Istanbul Saglik Bilimleri University
Organization:
Study Overview
Official Title:
Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection: Incidence, Risk Factors, Predictors and Relation with Patient Outcomes: a Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2025-01
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:
Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes.
Detailed Description:
Hepatic resections are highly invasive major surgical procedures and are associated with higher incidence of end-organ injuries, specifically acute kidney injury (AKI) and perioperative myocardial injury (PMI). This study was designed to determine the incidences of AKI and PMI, and reveal the risk factors for their development and investigate intraoperative labaratory predictors in patients undergoing hepatic resection. We also planned to evaluate the relationship between the occurrence of end-organ injury and length of hospital and intensive care unit (ICU) stay, and 90-day mortality.
Patients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.
Patients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: