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| Name | Class |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments have revealed its beneficial effects against I/R injury, our goal is therefore to investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of DGF after kidney transplantation.
Participants will be randomly assigned, in a 1:1 ratio, to receive Edaravone or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Edaravone and 0.9 %NaCl solution will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded. The participation of each patient is scheduled for 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. |
|
| control group | Placebo Comparator | 100ml 0.9%%NaCl solution,but without edaravone, will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone | Drug | Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded.The participation of each patient is scheduled for 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DGF(postoperative complication after kidney transplantation)（%） | in the first week after the kidney transplantation | |
| serum creatinine value (umoI/L) | within the first week |
| Measure | Description | Time Frame |
|---|---|---|
| average daily urinary volume（ml） | within the first week | |
| Hospital stays after operation(d) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-ying Zhao | Contact | 13513616985 | zhaoxy06@163.com | |
| Qiang Wang | Contact | 86-29-84775343 | wangqiang@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang | Xijing Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386035 | Background | Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. | |
| 19100411 |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
|
| 0.9%%NaCl solution | Drug | 100ml 0.9%%NaCl solution,but without edaravone ,will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg |
|
|
| graft survival |
| within 30 days after surgery |
| other postoperative complication:acute rejection episodes、thrombosis、infections | within 30 days after surgery |
| Content of Malondialdehyde（mol/m l）in the blood | before transplantation and 1, 2, 3 days after transplantation |
| Content of Superoxide dismutase（U /m l) in the blood | before transplantation and 1, 2, 3 days after transplantation |
| Shah VR, Butala BP, Parikh GP, Vora KS, Parikh BK, Modi MP, Bhosale GP, Mehta T. Combined epidural and general anesthesia for paediatric renal transplantation-a single center experience. Transplant Proc. 2008 Dec;40(10):3451-4. doi: 10.1016/j.transproceed.2008.06.065. |
| 16412242 | Background | Kontodimopoulos N, Niakas D. Overcoming inherent problems of preference-based techniques for measuring health benefits: an empirical study in the context of kidney transplantation. BMC Health Serv Res. 2006 Jan 14;6:3. doi: 10.1186/1472-6963-6-3. |
| 8996759 | Background | Ibrahim S, Jacobs F, Zukin Y, Enriquez D, Holt D, Baldwin W 3rd, Sanfilippo F, Ratner LE. Immunohistochemical manifestations of unilateral kidney ischemia. Clin Transplant. 1996 Dec;10(6 Pt 2):646-52. |
| 9112349 | Background | Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011. |
| 15541456 | Background | Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |