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Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

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ClinicalTrials.gov Identifier: NCT02174575
Recruitment Status : Unknown
Verified April 2016 by Koshi Makita, Tokyo Medical and Dental University.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Koshi Makita, Tokyo Medical and Dental University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatoma Cholangiocarcinoma Gallbladder Neoplasms Drug: Sevoflurane Drug: Desflurane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Postoperative acute kidney injury [ Time Frame: within 72 hours postoperatively ]
    Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174575


Locations
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Japan
Tokyo Medical and Dental University Recruiting
Tokyo, Japan, 113-8519
Contact: Koshi Makita, M.D.    81-3-5803-5325    makita.mane@tmd.ac.jp   
Principal Investigator: Koshi Makita, M.D.         
Sponsors and Collaborators
Tokyo Medical and Dental University
Investigators
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Principal Investigator: Koshi Makita, M.D. Tokyo Medical and Dental University

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Responsible Party: Koshi Makita, Professor, Tokyo Medical and Dental University
ClinicalTrials.gov Identifier: NCT02174575     History of Changes
Other Study ID Numbers: TMDU-1490
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Koshi Makita, Tokyo Medical and Dental University:
Hepatectomy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Cholangiocarcinoma
Gallbladder Neoplasms
Acute Kidney Injury
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Anesthetics
Sevoflurane
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General