- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644915
Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients (I/R)
Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qiang Wang
- Phone Number: 86-29-84775343
- Email: wangqiang@fmmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
- Age 18yrs-55yrs for donors and the recipients
- patients under hemodialysis
- no other severe complications history for the donors and recipients
- the first kidney transplant recipients
- patients with written informed consent
Exclusion Criteria:
- ASA Ⅳ
- a second renal transplant,a multiorgan transplant or a dual kidney transplant
- having severe comorbidity history,for example,severe cardiac dysfunction
- cold ischemia time>24h or warm ischemia time>45min
- variation of blood vessel ,operation time more than 2 hours
- bleeding volume in operation>500ml and need for blood transfusion
- participate in the other clinical trial 3 months before the enrollment
- no suitable to participate in this experiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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. |
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:
|
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of DGF(postoperative complication after kidney transplantation)(%)
Time Frame: in the first week after the kidney transplantation
|
in the first week after the kidney transplantation
|
serum creatinine value (umoI/L)
Time Frame: within the first week
|
within the first week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
average daily urinary volume(ml)
Time Frame: within the first week
|
within the first week
|
Hospital stays after operation(d)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
graft survival
Time Frame: within 30 days after surgery
|
within 30 days after surgery
|
other postoperative complication:acute rejection episodes、thrombosis、infections
Time Frame: within 30 days after surgery
|
within 30 days after surgery
|
Content of Malondialdehyde(mol/m l)in the blood
Time Frame: before transplantation and 1, 2, 3 days after transplantation
|
before transplantation and 1, 2, 3 days after transplantation
|
Content of Superoxide dismutase(U /m l) in the blood
Time Frame: before transplantation and 1, 2, 3 days after transplantation
|
before transplantation and 1, 2, 3 days after transplantation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Qiang Wang, Xijing Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zxy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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