Clinical trial NCT06775158: Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasm
Kidney Injury, Acute
Myocardial Injury After Non-Cardiac Surgery
Keywords: Hepatic resection
acute kidney injury
perioperative myocardial injury
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients sufferd from Acute Kidney injury
timeFrame: 3 days postoperatively
measure: Number of patients suffered from Perioperative myocardial injury
timeFrame: 3 days postoperatively
measure: Number of patients suffered from perioperative organ injury
timeFrame: 3 days postoperatively
measure: Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury
timeFrame: 3 days postoperatively
Secondary outcomes:
measure: Length of intensive care unit stay
timeFrame: 90 days postoperatively
measure: Length of hospital stay
timeFrame: 90 days postoperatively
measure: 90-day mortality
timeFrame: 90 days postoperatively
Other outcomes:
measure: Area under the curve of receiver operating characteristics curve generated by using intraoperative Lactate, base excess, venous saturation and delta carbondioxide pressure
timeFrame: 3 days postoperatively
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam&Sakura City Hospital
Study officials:
References: