Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

NCT06775158 | Completed

• 1 other identifier: 27..2024.297
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hepatic resection; acute kidney injury; perioperative myocardial injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Length of intensive care unit stay

  90 days postoperatively

• Length of hospital stay

  90 days postoperatively

• 90-day mortality

  90 days postoperatively

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

  3 days postoperatively

Study Arms (2)

Patients with organ injury

Patitents who suffered from AKI or PMI

Patients without organ injury

Patitents who did not suffer from AKI or PMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who underwent hepatic resection

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Başakşehir Çam&Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver Neoplasms; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 14, 2025
• Study Start: June 15, 2021
• Primary Completion: June 20, 2024
• Study Completion: September 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)