Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

Study Overview
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Brief Summary
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It has been shown that patients who undergo liver resection surgery are at high risk for postoperative acute kidney injury (AKI). Sevoflurane may increase the risk for postoperative AKI because of production of compound-A. Therefore, we have planned to investigate the effects of different anesthetic agents on postoperative renal function. Patients undergoing liver resection surgery are randomized into 2 groups. One of the groups receives sevoflurane and the other group receives desflurane. Blood and urine specimen are sampled both pre- and postoperatively, and several biomarkers are compared between the groups.

Detailed Description
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Design - This is a randomized, observer-blinded, controlled trial. Study objectives and hypothesis - The aim of this study is to prove the hypothesis that desflurane is safer than sevoflurane in terms of the association with postoperative acute kidney injury (AKI) after liver resection surgery. Inclusion and exclusion criteria Inclusion criteria: Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included. Exclusion criteria: Patients who undergo less invasive liver resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study (e.g., desflurane, sevoflurane, propofol, remifentanil, rocuronium) are also excluded. Outcome definition - AKI is diagnosed based on RIFLE creatinine criteria within 72 hours postoperatively. Serum creatinine is measured preoperatively, on the day of the surgery, and 1st, 2nd, and 3rd postoperative days. Methods Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the agent administered during anesthesia For the quantitative analysis for subclinical AKI, urine interleukin-6 (IL-6), plasma and urine neutrophil gelatinase-associated lipocalin (NGAL), serum cystatin C, urine liver-type fatty acid-binding protein (L-FABP), urine N-acetyl-β-D-Glucosaminidase (NAG), and urine albumin concentration are measured preoperatively, on the day of the surgery, and 1st postoperative day. Demographic data, preoperative medication, past medical history, perioperative data related to anesthesia and surgery, and data related to outcome are also sampled. Postoperative clinical course is followed until the patients are discharged. Incidence rate of postoperative AKI and biomarkers are compared between the groups.

Official Title
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Effects of Different Inhalational Anesthetic Agents on the Incidence of Clinical and Subclinical Acute Kidney Injury After Liver Resection Surgery: a Pilot Study

Conditions
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Hepatocellular Carcinoma, Hepatoma, Cholangiocarcinoma, Gallbladder Neoplasms

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included. Exclusion Criteria: Patients who undergo less invasive resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study are also excluded.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. | Drug: Sevoflurane<br>* Sevoflurane is administered during anesthesia in Sevoflurane group.<br>|
| Active Comparator: Desflurane<br>Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. | Drug: Desflurane<br>* Desflurane is administered during anesthesia in Desflurane group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative acute kidney injury | Postoperative acute kidney injury is defined based on RIFLE creatinine criteria. | within 72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine IL-6 concentration | Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Plasma NGAL concentration | Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Urine NGAL concentration | Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Serum cystatin C concentration | Serum cystatin C concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Urine L-FABP concentration | Urine L-FABP concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Urine NAG concentration | Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 
| Urine albumin concentration | Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatectomy