Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
NCT ID: NCT02621281
Last Updated: 2017-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2015-12-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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cold storage
In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
cold storage
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
Kidney Transporter machines
In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
Kidney Transporter machines
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
Interventions
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Kidney Transporter machines
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
cold storage
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
Eligibility Criteria
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Inclusion Criteria
1. Comply with the national DCD（donor after citizen death) guideline
2. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
3. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
4. No active, untreated systemic bacterial, viral or fungal infection;
5. Patients definitely identified
6. Mechanical perfusion RI (resistance index ) \[0.18, 0.50\]
Recipient:
1. Age\> = 16 years old, male or female
2. BMI\<28
3. First Renal transplantation
4. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
5. Before the clinical trial, Patient sign informed consent voluntarily
Exclusion Criteria
1. Older than 50 years old
2. Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
3. Donor kidney cold storage time over 30 hours
4. Warm ischemia time over 20 minutes
5. Other reagents are added perfusion for regulation of donor renal function
Recipient:
1. Double organ or multi-organ transplant
2. Blood type-incompatible
3. Patients with other malignant diseases
16 Years
ALL
No
Sponsors
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The First Hospital of Jilin University
OTHER
303rd Hospital of the People's Liberation Army
OTHER
Fuzhou General Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Ding,Chenguang
PHD
Principal Investigators
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Wujun Xue, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Xian Jiaotong University
Locations
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First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
Moers C, Pirenne J, Paul A, Ploeg RJ; Machine Preservation Trial Study Group. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2012 Feb 23;366(8):770-1. doi: 10.1056/NEJMc1111038. No abstract available.
Tapiawala SN, Tinckam KJ, Cardella CJ, Schiff J, Cattran DC, Cole EH, Kim SJ. Delayed graft function and the risk for death with a functioning graft. J Am Soc Nephrol. 2010 Jan;21(1):153-61. doi: 10.1681/ASN.2009040412. Epub 2009 Oct 29.
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.
Yarlagadda SG, Coca SG, Formica RN Jr, Poggio ED, Parikh CR. Association between delayed graft function and allograft and patient survival: a systematic review and meta-analysis. Nephrol Dial Transplant. 2009 Mar;24(3):1039-47. doi: 10.1093/ndt/gfn667. Epub 2008 Dec 22.
Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. Machine perfusion versus cold storage for the preservation of kidneys donated after cardiac death: a multicenter, randomized, controlled trial. Ann Surg. 2010 Nov;252(5):756-64. doi: 10.1097/SLA.0b013e3181ffc256.
Treckmann J, Moers C, Smits JM, Gallinat A, Maathuis MH, van Kasterop-Kutz M, Jochmans I, Homan van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Pirenne J, Ploeg RJ, Paul A. Machine perfusion versus cold storage for preservation of kidneys from expanded criteria donors after brain death. Transpl Int. 2011 Jun;24(6):548-54. doi: 10.1111/j.1432-2277.2011.01232.x. Epub 2011 Feb 17.
Patel SK, Pankewycz OG, Nader ND, Zachariah M, Kohli R, Laftavi MR. Prognostic utility of hypothermic machine perfusion in deceased donor renal transplantation. Transplant Proc. 2012 Sep;44(7):2207-12. doi: 10.1016/j.transproceed.2012.07.129.
Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. The prognostic value of renal resistance during hypothermic machine perfusion of deceased donor kidneys. Am J Transplant. 2011 Oct;11(10):2214-20. doi: 10.1111/j.1600-6143.2011.03685.x. Epub 2011 Aug 11.
Doorschodt BM, Schreinemachers MC, Behbahani M, Florquin S, Weis J, Staat M, Tolba RH. Hypothermic machine perfusion of kidney grafts: which pressure is preferred? Ann Biomed Eng. 2011 Mar;39(3):1051-9. doi: 10.1007/s10439-010-0228-7. Epub 2010 Dec 16.
Patel SK, Pankewycz OG, Weber-Shrikant E, Zachariah M, Kohli R, Nader ND, Laftavi MR. Effect of increased pressure during pulsatile pump perfusion of deceased donor kidneys in transplantation. Transplant Proc. 2012 Sep;44(7):2202-6. doi: 10.1016/j.transproceed.2012.07.109.
Sung RS, Christensen LL, Leichtman AB, Greenstein SM, Distant DA, Wynn JJ, Stegall MD, Delmonico FL, Port FK. Determinants of discard of expanded criteria donor kidneys: impact of biopsy and machine perfusion. Am J Transplant. 2008 Apr;8(4):783-92. doi: 10.1111/j.1600-6143.2008.02157.x. Epub 2008 Feb 19.
Cantafio AW, Dick AA, Halldorson JB, Bakthavatsalam R, Reyes JD, Perkins JD. Risk stratification of kidneys from donation after cardiac death donors and the utility of machine perfusion. Clin Transplant. 2011 Sep-Oct;25(5):E530-40. doi: 10.1111/j.1399-0012.2011.01477.x. Epub 2011 May 18.
Akoh JA. Kidney donation after cardiac death. World J Nephrol. 2012 Jun 6;1(3):79-91. doi: 10.5527/wjn.v1.i3.79.
Chapal M, Le Borgne F, Legendre C, Kreis H, Mourad G, Garrigue V, Morelon E, Buron F, Rostaing L, Kamar N, Kessler M, Ladriere M, Soulillou JP, Launay K, Daguin P, Offredo L, Giral M, Foucher Y. A useful scoring system for the prediction and management of delayed graft function following kidney transplantation from cadaveric donors. Kidney Int. 2014 Dec;86(6):1130-9. doi: 10.1038/ki.2014.188. Epub 2014 Jun 4.
Irish WD, Ilsley JN, Schnitzler MA, Feng S, Brennan DC. A risk prediction model for delayed graft function in the current era of deceased donor renal transplantation. Am J Transplant. 2010 Oct;10(10):2279-86. doi: 10.1111/j.1600-6143.2010.03179.x.
Jeldres C, Cardinal H, Duclos A, Shariat SF, Suardi N, Capitanio U, Hebert MJ, Karakiewicz PI. Prediction of delayed graft function after renal transplantation. Can Urol Assoc J. 2009 Oct;3(5):377-82. doi: 10.5489/cuaj.1147.
Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
Other Identifiers
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LPT-G-1501
Identifier Type: -
Identifier Source: org_study_id
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