Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: study group 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. |
Drug: Edaravone
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.
Other Names:
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| Placebo Comparator: control group 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. |
Drug: 0.9%%NaCl solution
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
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
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Age 18yrs-55yrs for donors and the recipients
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patients under hemodialysis
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no other severe complications history for the donors and recipients
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the first kidney transplant recipients
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patients with written informed consent
Exclusion Criteria:
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ASA Ⅳ
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a second renal transplant,a multiorgan transplant or a dual kidney transplant
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having severe comorbidity history,for example,severe cardiac dysfunction
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cold ischemia time>24h or warm ischemia time>45min
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variation of blood vessel ，operation time more than 2 hours
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bleeding volume in operation>500ml and need for blood transfusion
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participate in the other clinical trial 3 months before the enrollment
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no suitable to participate in this experiment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xijing Hospital
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
- Study Chair: Qiang Wang, Xijing Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. Review.
- 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.
- 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. Erratum in: Lancet. 2012 Aug 18;380(9842):650.
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