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I retired my post before enrollment
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Active Comparator | Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. |
|
| Desflurane | Active Comparator | Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Sevoflurane is administered during anesthesia in Sevoflurane group. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative acute kidney injury | Postoperative acute kidney injury is defined based on RIFLE creatinine criteria. | within 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma NGAL concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koshi Makita, M.D. | Tokyo Medical and Dental University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University | Tokyo | 113-8519 | Japan |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Desflurane |
| Drug |
Desflurane is administered during anesthesia in Desflurane group. |
|
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 | 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 | 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 | 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 | 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 | Urine albumin concentration is measured pre- and postoperatively to detect subclinical acute kidney injury. | On the day of surgery and postoperative day 1 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005019 | Ethyl Ethers |