Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

NCT ID: NCT02174575

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2023-05-31

Brief 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.

Conditions

Hepatocellular Carcinoma; Hepatoma; Cholangiocarcinoma; Gallbladder Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sevoflurane

Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

Sevoflurane is administered during anesthesia in Sevoflurane group.

Desflurane

Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.

Group Type: ACTIVE_COMPARATOR

Desflurane

Intervention Type: DRUG

Desflurane is administered during anesthesia in Desflurane group.

Interventions

Sevoflurane

Sevoflurane is administered during anesthesia in Sevoflurane group.

Intervention Type: DRUG

Desflurane

Desflurane is administered during anesthesia in Desflurane group.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Medical and Dental University

OTHER

Sponsor Role: lead

Responsible Party

Koshi Makita, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koshi Makita, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical and Dental University

Locations

Tokyo Medical and Dental University

Tokyo, , Japan

Countries

Japan

Other Identifiers

TMDU-1490

Identifier Type: -

Identifier Source: org_study_id