Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection

NCT ID: NCT06775158

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with organ injury

Patitents who suffered from AKI or PMI

No interventions assigned to this group

Patients without organ injury

Patitents who did not suffer from AKI or PMI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Saglik Bilimleri University

OTHER

Sponsor Role lead

Responsible Party

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Taner Abdullah

Specialist in Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başakşehir Çam&Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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27..2024.297

Identifier Type: -

Identifier Source: org_study_id

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