Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

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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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Postoperative acute kidney injury

Secondary Outcome

 Urine IL-6 concentration

Condition

Hepatocellular Carcinoma

Intervention

Sevoflurane

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

July 2014

Completion Date

December 2016

Primary Completion Date

December 2016

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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Koshi Makita, M.D., , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02174575

Organization ID

TMDU-1490


Responsible Party

Principal Investigator

Study Sponsor

Tokyo Medical and Dental University


Study Sponsor

Koshi Makita, M.D., Principal Investigator, Tokyo Medical and Dental University


Verification Date

April 2016