Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

Phase 4

Withdrawn

• Conditions: Hepatocellular Carcinoma; Hepatoma; Cholangiocarcinoma; Gallbladder Neoplasms
• Interventions: Drug: Desflurane; Drug: Sevoflurane

• Registration Number: NCT02174575
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Start: 2014-07
• Status Verified: 2023-05
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury	within 72 hours postoperatively	Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.

Secondary Outcome Measures

Name	Time	Method
Urine IL-6 concentration	On the day of surgery and postoperative day 1	Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine NGAL concentration	On the day of surgery and postoperative day 1	Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Urine albumin concentration	On the day of surgery and postoperative day 1	Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Plasma NGAL concentration	On the day of surgery and postoperative day 1	Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Serum cystatin C concentration	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	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	On the day of surgery and postoperative day 1	Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.

Trial Locations

Locations (1)

Tokyo Medical and Dental University; 🇯🇵 Tokyo, Japan