- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174575
Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery
Effects of Different Inhalational Anesthetic Agents on the Incidence of Clinical and Subclinical Acute Kidney Injury After Liver Resection Surgery: a Pilot Study
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Design
- This is a randomized, observer-blinded, controlled trial.
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.
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.
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.
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 Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Desflurane is administered during anesthesia in Desflurane group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative acute kidney injury
Time Frame: within 72 hours postoperatively
|
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
|
within 72 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
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.
|
On the day of surgery and postoperative day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Renal Insufficiency
- Gallbladder Diseases
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Acute Kidney Injury
- Cholangiocarcinoma
- Gallbladder Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Desflurane
- Sevoflurane
Other Study ID Numbers
- TMDU-1490
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