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Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased costs, morbidity, and mortality. Dexmedetomidine has known to have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.
Acute kidney injury (AKI) following liver transplantation (LT) has shown a wide range of incidence between 17% and 95% and is associated with increased costs, morbidity, and mortality. The etiology of AKI after LT is multifactorial. Among these factors, renal ischemia-reperfusion injury (IRI) caused by perioperative renal hypoperfusion is considered as one of the most important independent risk factors and recent reports have indicated that IRI is associated with an inflammatory cascade. Dexmedetomidine which is a highly selective agonist of α2-adrenergic receptors has known have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour |
|
| treatment group | Active Comparator | The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute kidney injury | serum creatinine levels in postoperative 7 days | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| lactate level | serial lactate level during operation and postoperative 3 days | 3 days |
| delirium | The incidence of delirium | postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-Gol Song, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | Songpa-gu | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3556303 | Background | Rimola A, Gavaler JS, Schade RR, el-Lankany S, Starzl TE, Van Thiel DH. Effects of renal impairment on liver transplantation. Gastroenterology. 1987 Jul;93(1):148-56. doi: 10.1016/0016-5085(87)90327-1. | |
| 26603801 | Background | Wyssusek KH, Keys AL, Yung J, Moloney ET, Sivalingam P, Paul SK. Evaluation of perioperative predictors of acute kidney injury post orthotopic liver transplantation. Anaesth Intensive Care. 2015 Nov;43(6):757-63. doi: 10.1177/0310057X1504300614. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 22, 2024 | |
| Reset | Aug 2, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2019 | Dec 16, 2021 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 22, 2024 | Aug 2, 2024 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal saline | Drug | The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour |
|
| early allograft dysfunction | early allograft dysfunction | postoperative day 7 |
| duration of mechanical ventilation | duration of mechanical ventilation (hours) | up to 1 year |
| intensive care unit length of stay | intensive care unit length of stay (days) | up to 1 year |
| hospital length of stay | hospital length of stay (days) | up to 1 year |
| graft failure | recipient death or re-transplantation within 1 year | 1 year |
| 26444030 | Background | Cho JS, Shim JK, Soh S, Kim MK, Kwak YL. Perioperative dexmedetomidine reduces the incidence and severity of acute kidney injury following valvular heart surgery. Kidney Int. 2016 Mar;89(3):693-700. doi: 10.1038/ki.2015.306. |
| 29334927 | Background | Liu Y, Sheng B, Wang S, Lu F, Zhen J, Chen W. Dexmedetomidine prevents acute kidney injury after adult cardiac surgery: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2018 Jan 15;18(1):7. doi: 10.1186/s12871-018-0472-1. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004066 | Digestive System Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |