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Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

Primary Purpose

Hepatocellular Carcinoma, Hepatoma, Cholangiocarcinoma

Status
Withdrawn
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
Tokyo Medical and Dental University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring Hepatectomy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tokyo Medical and Dental University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sevoflurane

Desflurane

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative acute kidney injury
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.

Secondary Outcome Measures

Urine IL-6 concentration
Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Plasma NGAL concentration
Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine NGAL concentration
Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Serum cystatin C concentration
Serum cystatin C concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine L-FABP concentration
Urine L-FABP concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine NAG concentration
Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine albumin concentration
Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.

Full Information

First Posted
June 20, 2014
Last Updated
May 1, 2023
Sponsor
Tokyo Medical and Dental University
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1. Study Identification

Unique Protocol Identification Number
NCT02174575
Brief Title
Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery
Official Title
Effects of Different Inhalational Anesthetic Agents on the Incidence of Clinical and Subclinical Acute Kidney Injury After Liver Resection Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
I retired my post before enrollment
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2023 (Actual)
Study Completion Date
May 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Medical and Dental University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatoma, Cholangiocarcinoma, Gallbladder Neoplasms
Keywords
Hepatectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane is administered during anesthesia in Sevoflurane group.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Desflurane is administered during anesthesia in Desflurane group.
Primary Outcome Measure Information:
Title
Postoperative acute kidney injury
Description
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
Time Frame
within 72 hours postoperatively
Secondary Outcome Measure Information:
Title
Urine IL-6 concentration
Description
Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Plasma NGAL concentration
Description
Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Urine NGAL concentration
Description
Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Serum cystatin C concentration
Description
Serum cystatin C concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Urine L-FABP concentration
Description
Urine L-FABP concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Urine NAG concentration
Description
Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1
Title
Urine albumin concentration
Description
Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Time Frame
On the day of surgery and postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koshi Makita, M.D.
Organizational Affiliation
Tokyo Medical and Dental University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan

12. IPD Sharing Statement

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Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

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