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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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2014
Longer than P75 for phase_4 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMay 3, 2023
May 1, 2023
8.8 years
June 20, 2014
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative acute kidney injury
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
within 72 hours postoperatively
Secondary Outcomes (7)
Urine IL-6 concentration
On the day of surgery and postoperative day 1
Plasma NGAL concentration
On the day of surgery and postoperative day 1
Urine NGAL concentration
On the day of surgery and postoperative day 1
Serum cystatin C concentration
On the day of surgery and postoperative day 1
Urine L-FABP concentration
On the day of surgery and postoperative day 1
- +2 more secondary outcomes
Study Arms (2)
Sevoflurane
ACTIVE COMPARATORPatients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
Desflurane
ACTIVE COMPARATORPatients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
Interventions
Eligibility Criteria
You may qualify if:
- Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Medical and Dental University
Tokyo, 113-8519, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Koshi Makita, M.D.
Tokyo Medical and Dental University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2014
First Posted
June 25, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
May 3, 2023
Record last verified: 2023-05