Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients

Kidney Transplantation Clinical Trial

— I/R  

Official title:

Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02644915
• Other study ID #: zxy
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 30, 2015
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Xiao-ying Zhao
• Phone: 13513616985
• Email: zhaoxy06[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. ASA?-?,elective operation patients with end-stage renal disease

2. Age 18yrs-55yrs for donors and the recipients

3. patients under hemodialysis

4. no other severe complications history for the donors and recipients

5. the first kidney transplant recipients

6. patients with written informed consent

Exclusion Criteria:

1. ASA ?

2. a second renal transplant,a multiorgan transplant or a dual kidney transplant

3. having severe comorbidity history,for example,severe cardiac dysfunction

4. cold ischemia time>24h or warm ischemia time>45min

5. variation of blood vessel ,operation time more than 2 hours

6. bleeding volume in operation>500ml and need for blood transfusion

7. participate in the other clinical trial 3 months before the enrollment

8. no suitable to participate in this experiment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	The First Affiliated Hospital of Xi'an Jiao Tong University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DGF(postoperative complication after kidney transplantation)(%)		in the first week after the kidney transplantation	No
Primary	serum creatinine value (umoI/L)		within the first week	No
Secondary	average daily urinary volume(ml)		within the first week	No
Secondary	Hospital stays after operation(d)		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	graft survival		within 30 days after surgery	No
Secondary	other postoperative complication:acute rejection episodes?thrombosis?infections		within 30 days after surgery	No
Secondary	Content of Malondialdehyde(mol/m l)in the blood		before transplantation and 1, 2, 3 days after transplantation	No
Secondary	Content of Superoxide dismutase(U /m l) in the blood		before transplantation and 1, 2, 3 days after transplantation	No