Clinical trial NCT02174575: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Hepatoma
Cholangiocarcinoma
Gallbladder Neoplasms
Keywords: Hepatectomy
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: within 72 hours postoperatively
Secondary outcomes:
measure: Urine IL-6 concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Plasma NGAL concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Urine NGAL concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Serum cystatin C concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Urine L-FABP concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Urine NAG concentration
timeFrame: On the day of surgery and postoperative day 1
measure: Urine albumin concentration
timeFrame: On the day of surgery and postoperative day 1
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
Study officials:
affiliation: Tokyo Medical and Dental University
name: Koshi Makita, M.D.
role: PRINCIPAL_INVESTIGATOR
References: