Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery
Conditions
Hepatocellular Carcinoma - Hepatoma - Cholangiocarcinoma - Gallbladder Neoplasms
Conditions: official terms
Acute Kidney Injury - Carcinoma, Hepatocellular - Cholangiocarcinoma - Gallbladder Neoplasms
Conditions: Keywords
Hepatectomy
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Sevoflurane Type: Drug
Name: Desflurane Type: Drug
Overall Status
Recruiting
Summary
- 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
1. Design

- This is a randomized, observer-blinded, controlled trial.

2. 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.

3. 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.

4. 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.

5. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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 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.
Location
Tokyo Medical and Dental University
Tokyo, Japan
Status: Recruiting
Contact: Koshi Makita, M.D. - 81-3-5803-5325 - makita.mane@tmd.ac.jp
Start Date
July 2014
Completion Date
March 2016
Sponsors
Tokyo Medical and Dental University
Source
Tokyo Medical and Dental University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page