Kidney GraftOPTI-PMO 2NCT06907758
Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient
An observational study of Kidney Graft, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Graft
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to 10 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Subject adulte
Who may be able to join
- The inclusion criteria for organ donor patients are as follows:
- Adult patient
- Brain dead
- Hospitalized in surgical intensive care at Strasbourg University Hospital (NHC cardiovascular intensive care unit, NHC multi-purpose intensive care unit, Hautepierre surgical intensive care unit) from January 1, 2018 to December 31, 2023
- Having undergone multi-organ transplantation
- At least one of the donor kidneys has been transplanted to a patient at Strasbourg University Hospital
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- Absence of written objection in the medical file of the subject (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.
- The inclusion criteria for kidney transplant recipients are as follows:
- Adult patient
- Recipient of a kidney transplant from an organ donor who meets the inclusion criteria for donor patients mentioned above
- Patient who has undergone surgery and is hospitalized post-operatively at Strasbourg University Hospital
- Patient monitored by the Strasbourg University Hospital transplant team
- Absence of written objection in the subject's medical file (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.
Who cannot join
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
- Brain-dead patient who has not undergone organ retrieval
- Brain-dead patient whose kidney has not been allocated to a recipient in Strasbourg
- Patient transferred to the Strasbourg University Hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval
- Kidney transplant patient with a graft from a living donor
- Kidney transplant patient with a graft from a deceased donor who is not brain-dead
- Kidney transplant patient with a graft from a deceased donor who is brain-dead and hospitalized in a hospital other than Strasbourg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie, Réanimation et Médecine Périopératoire - CHU de Strasbourg - France
Strasbourg, 67091
Charlotte POUSSARDIN, MD, 33.3.69.55.16.21, charlotte.poussardin@chru-strasbourg.fr
Charlotte POUSSARDIN, MD
About this study
Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity.
Graft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors.
Through this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. For simplicity, the investigators will focus on kidney grafts. The aim is to improve the effectiveness of the transplant and reduce waiting times.
- Conditions
- Kidney Graft
- Keywords
- Kidney Graft, Grafts, Organ transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of creatinine decrease
Ratio of creatinine decrease on days 1 and 2 in kidney transplant recipients (formula: CRR2% = ((Cr1-Cr2)*100)/Cr1) or the need for dialysis before day 2.
Measured: Days 1 and 2 in kidney transplant recipients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start10 Apr 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney GraftStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907758
- Sponsor's protocol ID
- 9245
- Acronym
- OPTI-PMO 2
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient
- ClinicalTrials.gov ID
- NCT06907758
- Acronym / sponsor ID
- OPTI-PMO 2 / 9245
- Conditions
- Kidney Graft
- Keywords
- Kidney Graft, Grafts, Organ transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- 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.
Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity.
Graft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors.
Through this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. For simplicity, the investigators will focus on kidney grafts. The aim is to improve the effectiveness of the transplant and reduce waiting times.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subject adulte
Key inclusion criteria (13 listed)
- Adult patient
- Brain dead
- Hospitalized in surgical intensive care at Strasbourg University Hospital (NHC cardiovascular intensive care unit, NHC multi-purpose intensive care unit, Hautepierre surgical intensive care unit) from January 1, 2018 to December 31, 2023
- Having undergone multi-organ transplantation
- At least one of the donor kidneys has been transplanted to a patient at Strasbourg University Hospital
Key exclusion criteria (7 listed)
- Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
- Brain-dead patient who has not undergone organ retrieval
- Brain-dead patient whose kidney has not been allocated to a recipient in Strasbourg
- Patient transferred to the Strasbourg University Hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval
- Kidney transplant patient with a graft from a living donor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ratio of creatinine decrease
Time frame: Days 1 and 2 in kidney transplant recipients
Ratio of creatinine decrease on days 1 and 2 in kidney transplant recipients (formula: CRR2% = ((Cr1-Cr2)*100)/Cr1) or the need for dialysis before day 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Graft, run by University Hospital, Strasbourg, France 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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte POUSSARDIN, MD (33.3.69.55.16.21, charlotte.poussardin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of creatinine decrease (time frame: Days 1 and 2 in kidney transplant recipients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.