Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

May 1, 2023 updated by: Koshi Makita, MD, Tokyo Medical and Dental University

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

  • 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative acute kidney injury
Time Frame: within 72 hours postoperatively
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
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
Time Frame: On the day of surgery and postoperative day 1
Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
On the day of surgery and postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Medical and Dental University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMDU-1490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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