Hepatocellular CarcinomaPhase 4NCT02174575
Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery
A Phase 4 study testing Sevoflurane and Desflurane in people with Hepatocellular Carcinoma and Hepatoma, run by Tokyo Medical and Dental University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatoma, Cholangiocarcinoma
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
Read the 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.
- Being tested
- Sevoflurane, Desflurane
- Keywords
- Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane is administered during anesthesia in Sevoflurane group.
DesfluraneDrug
Desflurane is administered during anesthesia in Desflurane group.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. Receives: Drug: Sevoflurane |
| Desflurane | Active comparator | Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
Measured: within 72 hours postoperatively
Secondary outcomes (7)
Urine IL-6 concentration
Urine IL-6 concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Plasma NGAL concentration
Plasma NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Urine NGAL concentration
Urine NGAL concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Serum cystatin C concentration
Serum cystatin C concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Urine L-FABP concentration
Urine L-FABP concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Urine NAG concentration
Urine NAG concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Urine albumin concentration
Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury.
Measured: On the day of surgery and postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2023
- Study completionMay 2023
Why it stopped: I retired my post before enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical and Dental University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koshi Makita, MD, Tokyo Medical and Dental University
- Investigators
- Koshi Makita, M.D., Principal investigator, Tokyo Medical and Dental University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174575
- Sponsor's protocol ID
- TMDU-1490
- Status last verified
- May 2023
- First submitted
- 20 Jun 2014
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02174575
- Acronym / sponsor ID
- TMDU-1490
- Keywords
- Hepatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: I retired my post before enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tokyo Medical and Dental UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluranePatients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. |
| Desflurane | Active comparator | Drug: DesfluranePatients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane is administered during anesthesia in Sevoflurane group. | Drug | Sevoflurane |
| DesfluraneDesflurane is administered during anesthesia in Desflurane group. | Drug | Desflurane |
Primary outcome
Postoperative acute kidney injury
Time frame: within 72 hours postoperatively
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
7 secondary outcomes
Urine IL-6 concentration
Time frame: On the day of surgery and postoperative day 1
Plasma NGAL concentration
Time frame: On the day of surgery and postoperative day 1
Urine NGAL concentration
Time frame: On the day of surgery and postoperative day 1
Serum cystatin C concentration
Time frame: 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 NAG concentration
Time frame: On the day of surgery and postoperative day 1
Urine albumin concentration
Time frame: On the day of surgery and postoperative day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koshi Makita, M.D. principal investigator
Tokyo Medical and Dental University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Desflurane in people with Hepatocellular Carcinoma and Hepatoma, run by Tokyo Medical and Dental University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: within 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.