Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

Completed

• Conditions: Liver Neoplasm; Kidney Injury, Acute; Myocardial Injury After Non-Cardiac Surgery

• Registration Number: NCT06775158
• Lead Sponsor: Istanbul Saglik Bilimleri University

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.

Study Timeline

• Study Start: 2021-06-15
• Primary Completion: 2024-06-20
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-04
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Patients who underwent hepatic resection

Exclusion Criteria

• presence of end stage kidney disease
• emergency surgery
• application of total vascular exclusion
• concomitant gastrointestinal resection
• duration of surgery less than 100 minutes
• non-oncologic procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients sufferd from Acute Kidney injury	3 days postoperatively	at least 0.3mg/dL or 50% increase from baseline creatinine levels within 3 days postoperatively is described as Acute Kidney İnjury. Data will be presented as frequency(percentage) and the margin error of the percentage
Number of patients suffered from Perioperative myocardial injury	3 days postoperatively	At least 14 ng/L increase from baseline high sensitive Troponin T levels within 3 days psotoperatively is described as perioperative myocardial injury. Data will be presented as frequency(percentage) and the margin error of the percentage
Number of patients suffered from perioperative organ injury	3 days postoperatively	Occurence of acute kidney injury or perioperative myocardial injury within 3 days in patients undergoing hepatic resection. Descriptions are clarified in the prior outcomes' description sections. Data will be presented as frequency(percentage) and the margin error of the percentage
Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury	3 days postoperatively	Patients' demographic, medical and intraoperative characteristics will be evaluated in terms of the occurence of perioperative organ injury. Variables with the p value \< 0,05 will be added to the logistic regression model.

Secondary Outcome Measures

Name	Time	Method
Length of intensive care unit stay	90 days postoperatively	Length of intensive care unit stay during postoperative period will be evaluated in patients who did and did not suffer from perioperative organ injury
Length of hospital stay	90 days postoperatively	Length of hospital stay in the postoperative period, including intensive care will be evaluated in patients who did and did not suffer from perioperative organ injury
90-day mortality	90 days postoperatively	90-day mortality following the surgery will be evaluated in patients who did and did not suffer from perioperative organ injury

Trial Locations

Locations (1)

Başakşehir Çam&Sakura City Hospital; 🇹🇷 Istanbul, Turkey