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NCT Number: NCT06775158

Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

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.

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Key information

Conditions

Liver Neoplasm Acute Kidney Injury Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Injury, Acute Liver Diseases Liver Neoplasms Male Urogenital Diseases Myocardial Injury After Non-Cardiac Surgery Neoplasms Neoplasms by Site Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam&Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients sufferd from Acute Kidney injury

    Time frame: 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

  2. Number of patients suffered from Perioperative myocardial injury

    Time frame: 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

  3. Number of patients suffered from perioperative organ injury

    Time frame: 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

  4. Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury

    Time frame: 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 outcomes

  1. Length of intensive care unit stay

    Time frame: 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

  2. Length of hospital stay

    Time frame: 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

  3. 90-day mortality

    Time frame: 90 days postoperatively

    90-day mortality following the surgery will be evaluated in patients who did and did not suffer from perioperative organ injury

Other outcomes

  1. Area under the curve of receiver operating characteristics curve generated by using intraoperative Lactate, base excess, venous saturation and delta carbondioxide pressure

    Time frame: 3 days postoperatively

    intraoperative labaratory parameters obtained by arterai blood gas analysis will be evaluated by creating a model with logistic regression

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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