Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02174575
• Other study ID #: TMDU-1490
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: May 2023

Study information

• Verified date: May 2023
• Source: Tokyo Medical and Dental University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cholangiocarcinoma
• Gallbladder Neoplasms
• Hepatocellular Carcinoma
• Hepatoma

Intervention

Drug:
• Sevoflurane
Sevoflurane is administered during anesthesia in Sevoflurane group.
• Desflurane
Desflurane is administered during anesthesia in Desflurane group.

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative acute kidney injury	Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.	within 72 hours postoperatively
Secondary	Urine IL-6 concentration	Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Plasma NGAL concentration	Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Urine NGAL concentration	Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Serum cystatin C concentration	Serum cystatin C concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Urine L-FABP concentration	Urine L-FABP concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Urine NAG concentration	Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1
Secondary	Urine albumin concentration	Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.	On the day of surgery and postoperative day 1