Back to resultsClinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients (CIHMP)
Primary Purpose
Delayed Function of Renal Transplant
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Kidney Transporter machines
cold storage
Sponsored by
About this trial
This is an interventional other trial for Delayed Function of Renal Transplant focused on measuring hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure
Eligibility Criteria
Inclusion Criteria:
Donor
- Comply with the national DCD（donor after citizen death) guideline
- No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
- No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
- No active, untreated systemic bacterial, viral or fungal infection;
- Patients definitely identified
- Mechanical perfusion RI (resistance index ) [0.18, 0.50]
Recipient:
- Age> = 16 years old, male or female
- BMI<28
- First Renal transplantation
- Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
- Before the clinical trial, Patient sign informed consent voluntarily
Exclusion Criteria:
Donor
- Older than 50 years old
- Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
- Donor kidney cold storage time over 30 hours
- Warm ischemia time over 20 minutes
- Other reagents are added perfusion for regulation of donor renal function
Recipient:
- Double organ or multi-organ transplant
- Blood type-incompatible
- Patients with other malignant diseases
Sites / Locations
- First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cold storage
Kidney Transporter machines
Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02621281
First Posted
November 29, 2015
Last Updated
May 12, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02621281
Brief Title
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
Acronym
CIHMP
Official Title
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Function of Renal Transplant
Keywords
hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cold storage
Arm Type
Active Comparator
Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
Arm Title
Kidney Transporter machines
Arm Type
Active Comparator
Arm 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. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.
Intervention Type
Device
Intervention Name(s)
Kidney Transporter machines
Intervention Description
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
Intervention Type
Device
Intervention Name(s)
cold storage
Intervention Description
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
Primary Outcome Measure Information:
Title
The rate of Delayed graft function
Description
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.
Time Frame
the first week after transplant
Secondary Outcome Measure Information:
Title
Estimated Glomerular Filtration Rate
Description
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.
Time Frame
1 week, three months, six months, 12 months after kidney transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Donor
Comply with the national DCD（donor after citizen death) guideline
No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
No active, untreated systemic bacterial, viral or fungal infection;
Patients definitely identified
Mechanical perfusion RI (resistance index ) [0.18, 0.50]
Recipient:
Age> = 16 years old, male or female
BMI<28
First Renal transplantation
Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
Before the clinical trial, Patient sign informed consent voluntarily
Exclusion Criteria:
Donor
Older than 50 years old
Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
Donor kidney cold storage time over 30 hours
Warm ischemia time over 20 minutes
Other reagents are added perfusion for regulation of donor renal function
Recipient:
Double organ or multi-organ transplant
Blood type-incompatible
Patients with other malignant diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenguang Ding, PhD
Phone
+8615091152077
Email
doctor_ding@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wujun Xue, PhD
Phone
+8613991990128
Email
xwujun@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wujun Xue, PhD
Organizational Affiliation
The First Affiliated Hospital of Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenguang Ding, PhD
Email
doctor_ding@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
19118301
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-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
Results Reference
result
PubMed Identifier
22356343
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. No abstract available.
Results Reference
result
PubMed Identifier
19875806
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.
Results Reference
result
PubMed Identifier
15541456
Citation
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.
Results Reference
result
PubMed Identifier
19103734
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. Epub 2008 Dec 22.
Results Reference
result
PubMed Identifier
21037431
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, randomized, controlled trial. Ann Surg. 2010 Nov;252(5):756-64. doi: 10.1097/SLA.0b013e3181ffc256.
Results Reference
result
PubMed Identifier
21332580
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 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.
Results Reference
result
PubMed Identifier
22974956
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.
Results Reference
result
PubMed Identifier
21834917
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 Transplant. 2011 Oct;11(10):2214-20. doi: 10.1111/j.1600-6143.2011.03685.x. Epub 2011 Aug 11. Erratum In: Am J Transplant. 2012 Jan;12(1):267.
Results Reference
result
PubMed Identifier
21161683
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.
Results Reference
result
PubMed Identifier
22974955
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.transproceed.2012.07.109.
Results Reference
result
PubMed Identifier
18294347
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: 10.1111/j.1600-6143.2008.02157.x. Epub 2008 Feb 19.
Results Reference
result
PubMed Identifier
21585547
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.1399-0012.2011.01477.x. Epub 2011 May 18.
Results Reference
result
PubMed Identifier
24175245
Citation
Akoh JA. Kidney donation after cardiac death. World J Nephrol. 2012 Jun 6;1(3):79-91. doi: 10.5527/wjn.v1.i3.79.
Results Reference
result
PubMed Identifier
24897036
Citation
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.
Results Reference
result
PubMed Identifier
20883559
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.
Results Reference
result
PubMed Identifier
19829730
Citation
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.
Results Reference
result
Learn more about this trial
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
We'll reach out to this number within 24 hrs