Chronic Renal FailureIMPULSIONNCT01170910
Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors
A study testing Static incubation and Pulsatile perfusion in people with Chronic Renal Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Static incubation and Pulsatile perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- donors over 60 years of age
- donors between 50 and 60 years of age with at least one of the following characteristics :
- history of diabetes mellitus
- history of high blood pressure
- serum creatinine >1,5 mg/dL
- death by stroke (haemorrhagic or thrombotic)
- patients registered on the kidney transplant waiting list likely to receive a marginal kidney
- immunized patients whose anti-HLA antibody specificities have been determined
Who cannot join
- pregnant or breastfeeding women
- people who have been incarcerated
- minors
- adults under guardianship
- people who are not affiliated with the French healthcare system
- people with HLA immunization whose HLA antibody specificities have not been determined
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Urologie et Chirurgie de la Tranplantation - Hôpital Edourad Herriot
Lyon, 69437
About this study
Official title: Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors
Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant).
Observation or Investigation Method Used :
Read more
The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups:
- group 1 corresponds to a conservation of grafts in static incubation
- group 2 corresponds to conservation using a pulsatile perfusion machine
Duration and Organizational Arrangements for Research :
The total duration of the study is planned for 36 months. This duration includes:
- an inclusion period that will last 24 months,
- the follow-up of recipient patients from the day of transplantation until twelve months after the operation
- Conditions
- Chronic Renal Failure
- Being tested
- Static incubation, Pulsatile perfusion
- Keywords
- Chronic renal failure, Transplantation, Marginal kidney graft, Pulsatile perfusion machine
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static incubationProcedure or surgery
Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted.
.
Pulsatile perfusionProcedure or surgery
Kidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
| Study group | Role | What they receive |
|---|---|---|
| Static incubation | Other | If conservation in static incubation (group 1) is chosen by random selection, the transplant should be carried out while keeping the cold ischemic time (CIT) as short as possible (preferably less than 18 hours). Keep in mind that for reasons of homogeneity for result analysis and for conservation quality, it is recommended that kidneys in group 1 be conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution. Receives: Procedure: Static incubation |
| Pulsatile perfusion | Experimental | If conservation in a pulsatile perfusion machine (group 2) is chosen by random selection, the kidney will be placed in the perfusion machine within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted Receives: Procedure: Pulsatile perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload.
Measured: First week after transplantation
Secondary outcomes (7)
Evaluate improvement in the glomerular filtering rate
Measured: 12 months after transplantation
Evaluate the recourse to dialysis
Measured: 3 months following transplantation
Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)
Measured: 12 months after transplantation
Evaluate patient survival
Measured: 12 months after transplantation
Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion.
Measured: 12 months after transplantation
Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival
Measured: 12 months after transplantation
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts
Measured: 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170910
- Sponsor's protocol ID
- 2009.550/3
- Acronym
- IMPULSION
- Status last verified
- May 2017
- First submitted
- 26 Jul 2010
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38979743
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors
- ClinicalTrials.gov ID
- NCT01170910
- Acronym / sponsor ID
- IMPULSION / 2009.550/3
- Conditions
- Chronic Renal Failure
- Keywords
- Chronic renal failure, Transplantation, Marginal kidney graft, Pulsatile perfusion machine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant).
Observation or Investigation Method Used :
The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups:
- group 1 corresponds to a conservation of grafts in static incubation
- group 2 corresponds to conservation using a pulsatile perfusion machine
Duration and Organizational Arrangements for Research :
The total duration of the study is planned for 36 months. This duration includes:
- an inclusion period that will last 24 months,
- the follow-up of recipient patients from the day of transplantation until twelve months after the operation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static incubation | Other | Procedure: Static incubationIf conservation in static incubation (group 1) is chosen by random selection, the transplant should be carried out while keeping the cold ischemic time (CIT) as short as possible (preferably less than 18 hours). Keep in mind that for reasons of homogeneity for result analysis and for conservation quality, it is recommended that kidneys in group 1 be conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution. |
| Pulsatile perfusion | Experimental | Procedure: Pulsatile perfusionIf conservation in a pulsatile perfusion machine (group 2) is chosen by random selection, the kidney will be placed in the perfusion machine within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- donors over 60 years of age
- donors between 50 and 60 years of age with at least one of the following characteristics :
- patients registered on the kidney transplant waiting list likely to receive a marginal kidney
- immunized patients whose anti-HLA antibody specificities have been determined
Key exclusion criteria (6 listed)
- pregnant or breastfeeding women
- people who have been incarcerated
- minors
- adults under guardianship
- people who are not affiliated with the French healthcare system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static incubationKidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted. . | Procedure or surgery | Static incubation |
| Pulsatile perfusionKidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted | Procedure or surgery | Pulsatile perfusion |
Primary outcome
Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload.
Time frame: First week after transplantation
7 secondary outcomes
Evaluate improvement in the glomerular filtering rate
Time frame: 12 months after transplantation
Evaluate the recourse to dialysis
Time frame: 3 months following transplantation
Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis)
Time frame: 12 months after transplantation
Evaluate patient survival
Time frame: 12 months after transplantation
Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion.
Time frame: 12 months after transplantation
Identify perfusion profiles of the machine, which predict regaining renal function (absence of dialysis during the week after transplantation) and graft survival
Time frame: 12 months after transplantation
Evaluate the medico-economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts
Time frame: 12 months after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 38979743Tingle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static incubation and Pulsatile perfusion in people with Chronic Renal Failure, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload. (time frame: First week after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.