Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

Delayed Function of Renal Transplant Clinical Trial

— CIHMP  

Official title:

Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02621281
• Other study ID #: LPT-G-1501
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2015
• Last updated: May 12, 2017
• Start date: December 2015
• Est. completion date: January 2019

Study information

• Verified date: May 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Chenguang Ding, PhD
• Phone: +8615091152077
• Email: doctor_ding[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.

Description:

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. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Donor

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:

• Donor

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

Related Conditions & MeSH terms

• Delayed Function of Renal Transplant
• Hypothermia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	303rd Hospital of the People's Liberation Army, First Hospital of Jilin University, Fuzhou General Hospital

Country where clinical trial is conducted

China, 

References & Publications (17)

Akoh JA. Kidney donation after cardiac death. World J Nephrol. 2012 Jun 6;1(3):79-91. doi: 10.5527/wjn.v1.i3.79. Review. — View Citation

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.1399-001 — View Citation

Chapal M, Le Borgne F, Legendre C, Kreis H, Mourad G, Garrigue V, Morelon E, Buron F, Rostaing L, Kamar N, Kessler M, Ladrière M, Soulillou JP, Launay K, Daguin P, Offredo L, Giral M, Foucher Y. A useful scoring system for the prediction and management of — View Citation

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. — View Citation

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. — View Citation

Jeldres C, Cardinal H, Duclos A, Shariat SF, Suardi N, Capitanio U, Hébert MJ, Karakiewicz PI. Prediction of delayed graft function after renal transplantation. Can Urol Assoc J. 2009 Oct;3(5):377-82. — View Citation

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, rando — View Citation

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 Transplan — View Citation

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. — View Citation

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-dono — View Citation

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. — View Citation

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.transpr — 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

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: 1 — View Citation

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. — View Citation

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 preserva — View Citation

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. Ep — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Delayed graft function	Delayed graft function (DGF) is a common complication of renal transplantation. DGF can be diagnosed according to the three aspects below.; i. Need for postoperative dialysis: Need for dialysis in the first week after transplant once hyperacute rejection, vascular and urinary tract complications and hyperkalemia are ruled out.; ii. Urine output and serum creatinine: 1) Rise in serum Cr at 6-8 h post-operatively or <300 ml of urine despite adequate volume and diuretics. 2) Urine output <1 L in 24 h and <25% fall in serum creatinine from baseline in first 24 h post-transplant. 3) Urine output <75 mL/h in first 48 h or failure of serum Cr to decrease by 10% in the first 48 h. 4) Serum creatinine increases or remains unchanged or decreases <10%/day during 3 consecutive days postoperatively. 5) Serum creatinine >2.5mg/dL on Day 7 or need for post-transplant hemodialysis.6) Time required for the kidney to reach CrCl>10 mL/min greater than 1 week.	the first week after transplant
Secondary	Estimated Glomerular Filtration Rate	Glomerular filtration rate (GFR) is the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time.[3] Central to the physiologic maintenance of GFR is the differential basal tone of the afferent and efferent arterioles (see diagram). In other words, the filtration rate is dependent on the difference between the higher blood pressure created by vasoconstriction of the input or afferent arteriole versus the lower blood pressure created lesser vasoconstriction of the output or efferent arteriole.	1 week, three months, six months, 12 months after kidney transplant