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KPJ (kidney protective jacket) Feasibility Study

The effect of intraoperative thermal kidney insulation on current kidney transplantation surgical practices: a pilot feasibility study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001135808
Acronym
KPJFS
Enrollment
4
Registered
2021-08-23
Start date
2026-02-24
Completion date
2027-01-12
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a feasilibility study to determine if use of KPJ™ (Kidney Protective Jacket) during renal transplantation is feasible and implementable in the Australian kidney transplant setting. In addition, it shall also assess whether the KPJ™ improves transplantation outcomes from ‘marginal’ or higher risk grafts currently used for transplantation.

Interventions

Patients undergoing kidney transplantation from deceased or living donors including multiorgan transplantation (i.e. simultaneous pancreas and kidney transplants) shall be considered for enrolment. Patients must be aged 18 years and above. First and second transplant patients shall be accepted. The intervention is non-pharmacological. Donor kidneys will undergo preservation by cold storage followed by anatomosis to the recipient temporarily placed within the KPJ (kidney protective jacket). The k

Patients undergoing kidney transplantation from deceased or living donors including multiorgan transplantation (i.e. simultaneous pancreas and kidney transplants) shall be considered for enrolment. Patients must be aged 18 years and above. First and second transplant patients shall be accepted. The intervention is non-pharmacological. Donor kidneys will undergo preservation by cold storage followed by anatomosis to the recipient temporarily placed within the KPJ (kidney protective jacket). The kidney transplant shall be otherwise performed using standard techniques. Suitable kidneys will be placed in iiPJ after backtable preparation and left in cold storage (CS) until the recipient is ready for implantation. A non-invasive temperature of the exposed kidney at the hilum will be taken using a laser thermometer, directly prior to commencement of vascular anastomoses. When the recipient procedure has progressed to the reimplantation stage the KPJ with the donor kidney insitu will be taken out of the ice and CS into the operative field within the patient for anastomosis. Once renal artery and vein are anastomosed, the KPJ will be rapidly removed and discarded, the temperature of the kidney recorded using a non-invasive laser thermometer directly prior to reperfusion. The KPJ is to be used by the principal investigator and transplant team, all of whom have been trained in the use of the KPJ. The KPJ is a silicone kidney jacket that the kidney is placed into and secured via securing tabs to ensure the kidney does not fall out of the jacket. There is an opening at the top of the jacket through which the important vasculature is accessible. The KPJ is designed to thermally insulate the kidney from the outer environment of the open cavity of the recipient in order to slow down the thermal increase in the kidney's temperature over time. The KPJ is to be for the duration of the transplantation procedure from when the kidney is removed from ice till when anastomoses occurs of the important vasculature. This time period is approximately 30-45 minutes but could extend if surgical complications arise and the transplant takes longer than average (30 minutes at Westmead Hospital, 41 minutes global average). To monitor adherence to the intervention, surgical records shall be taken of: - usage of KPJ through transplant (KPJ used or not used) - time at which KPJ is placed on kidney - time at which KPJ is removed - further comments by surgical staff

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing kidney transplantation from deceased or living donors including multiorgan transplantation (i.e. simultaneous pancreas and kidney transplants).

Exclusion criteria

Patient deemed unfit for the usage of KPJ during the transplantation procedure by the principal investigator and transplant team. No paediatric recipient will be included in this trial. Patients who have either mental health or communication issues, such that they cannot consent or understand the trial will also be excluded. However, both of these are usually a contraindication to transplantation, if they are unable to comply with standard post-transplant care. Furthermore, patients undergoing their 3rd or more transplant or multi-organ transplantation will also be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026