Clinical Trial: Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

  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 t
      Sponsor: Tokyo Medical and Dental University

      Current Primary Outcome: Postoperative acute kidney injury [ Time Frame: within 72 hours postoperatively ]

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


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • 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.
      • 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.
      • 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.
      • 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.
      • 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.
      • 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.
      • 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.


      Original Secondary Outcome: Same as current

      Information By: Tokyo Medical and Dental University

      Dates:
      Date Received: June 20, 2014
      Date Started: July 2014
      Date Completion: December 2016
      Last Updated: April 20, 2016
      Last Verified: April 2016