Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection: Incidence, Risk Factors, Predictors and Relation with Patient Outcomes: a Retrospective Cohort Study

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34480
    • Başakşehir Çam&Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who underwent resection in Hepatobiliary&Pancreatic Surgery Clinic of Başakşehir Çam&Sakura City Hospital, between june 2021 and june 2024

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with organ injury; Patitents who suffered from AKI or PMI
Patients without organ injury; Patitents who did not suffer from AKI or PMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients sufferd from Acute Kidney injury	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	3 days postoperatively
Number of patients suffered from Perioperative myocardial injury	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	3 days postoperatively
Number of patients suffered from perioperative organ injury	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	3 days postoperatively
Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury	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.	3 days postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve of receiver operating characteristics curve generated by using intraoperative Lactate, base excess, venous saturation and delta carbondioxide pressure	intraoperative labaratory parameters obtained by arterai blood gas analysis will be evaluated by creating a model with logistic regression	3 days postoperatively

Collaborators and Investigators

• Sponsor: Istanbul Saglik Bilimleri University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: acute kidney injury; Hepatic resection; perioperative myocardial injury
• Additional Relevant MeSH Terms: Urogenital Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries; Liver Neoplasms
• Other Study ID Numbers: 27..2024.297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All raw data that will be used during the statitistical analysis will be shared by the primary investigator upon reosanable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No