Organ Donor Registration, Organ Failure, Multiple, Transplant Patients
Conditions
Brief summary
The goal of this observational study is to describe the details of a controlled administration strategy of cold preservation solution or oxygenated cold preservation solution at the end of Abdominal Normothermic Regional Perfusion (A-NRP) in Controlled Donation afeter Circulatory determination of Death (cDCD) III donors. The main purpose is to: develope a standardized protocol for this type of donor Data collected from partecipants, deceased donors belonging to cDCD III category, willl be analysed through descriptive stastistics.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Deceased donor screened for death according to category III cardiovascular criteria, according to the modified Maastricht classification, procured and subjected to Abdominal Normothermic Regional Perfusion (A-NRP); * Donor risk assessment as standard or negligible/acceptable non-standard risk, according to the nomenclature and guidelines of the National Transplant Center (risk definition is established by the CRT-ER, possibly after consulting with the national second opinion)
Exclusion criteria
* Presence of absolute contraindications to organ donation; * Dissent to donation expressed during life; * Opposition by eligible family members unless specifically expressing their wishes; * Unacceptable risk according to the National Transplant Center (CNT) guidelines; * Lack of authorization from the Prosecutor's Office in cases where required; * Infeasibility of the controlled administration of cold preservation solution with or without oxygenation, in the judgment of the first operator and/or the perfusionist in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Speed of administration of the preservation solution (mL/min) | the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. |
| Time required for administration of the preservation solution (h and min) | the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. |
| Occurence and type of mechanical complications (involving the extracorporeal circuit or the perfusion system in use) during controleld adminsitration of the preservation solution | the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. |
| Inability to perform reperfusion through the extracorporeal circuit and specific reasons | The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure of O2 (mm Hg) in the perfusate measured during perfusion at the end of the first bag of preservation solution and at the end of the last bag of preservation solution | 1 year and 3 months | — |
| Partial pressure of O2 (mm Hg) in the perfusate at the start of Ex-vivo Machine Perfusion (EVMP) | The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. | — |
| Somatic regional oxygen saturation (rSO2) measured at the renal level during reperfusion | The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data. | This parameter will be measured using near-infrared spectroscopy (NIRS) technology in each donor where feasible, considering the possibility of placing the sensors on the skin at a point where the distance from the renal cortex is no greater than 3-4 cm (The distance between the cortex and the skin surface will be measured bilaterally using transcutaneous ultrasound, locating the point of least depth) |
Countries
Italy
Outcome results
None listed