Kidney Transplant; ComplicationsQuitWITNCT05166460
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
A study testing Kidney cooling device in people with Kidney Transplant; Complications and Delayed Graft Function, run by Thomas Skinner at 1 site in Canada.
Trial summary
Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Delayed Graft Function
- What is being tested?
- Kidney cooling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to 15 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at time of transplant
- Slated to receive a single cadaveric organ
- Donor declared by traditional neurological determination of death (NDD)
- Standard criteria donor (SCD) or Extended criteria donor (ECD)
- Consent obtained prior to the transplant operation
Who cannot join
- Living donor (LD)
- Donor after cardiocirculatory death (DCD)
- Highly sensitized patients (those with Panel-reactive antibody or PRA >80%)
- Recipient of a previous kidney transplant
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Thomas Skinner, MD, 902-425-3940, thomas.skinner@nshealth.ca
Laura Sills, BSN, 902-473-7625, laura.sills@nshealth.ca
About this study
Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.
Read the detailed description
Warm ischemia can damage a renal allograft in many different ways often leading to early failure of the kidney transplant and sometimes even death of the transplant recipient. For this reason every effort is made to keep the allograft cold during the removal and transportation, and protocols have been developed to ensure this. Although kidneys are kept below 5°C during transportation, they re-warm rapidly during the transplant surgery. On average, kidneys are exposed to 40 or more minutes of dangerously warm temperatures during transplant surgery.
To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.
The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.
A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.
- Being tested
- Kidney cooling device
- Keywords
- kidney, transplant, warm ischemia time, delayed graft function, vascular anastomosis, renal hypothermia
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney cooling deviceDevice
Also called Kidney Skinn
renal cooling device designed to maintain renal hypothermia at or below 5ºC for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Surgery utilizing the Kidney Skinn cooling device | Experimental | All patients in Part A, and those randomized to the Kidney Skinn arm in Part B, will receive transplant surgery in the traditional fashion with the exception that the renal allograft will be placed in the cooling device at the initiation of the vascular anastomosis. Cold saline irrigation flowing through the device will be used to maintain renal hypothermia for the duration for the vascular anastomosis. After the vascular clamps are released, the device will be removed. Receives: Device: Kidney cooling device |
| Standard transplant surgery practice | No intervention | Standard transplant surgery per site practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)
The Kidney Skinn cooling device can be utilized during vascular anastomosis, and the ability of the device to maintain surface and core temperatures of transplant kidneys at <5ºC for the duration of the vascular anastomosis.
Measured: 6 months
Part B: To determine the feasibility of a trial using the Kidney Skinn cooling device to usual care to ameliorate warm ischemia time during kidney transplantation
Feasibility Outcomes will include the following:
- Ability to randomize >60% of eligible patients
- >75% of patients randomized to the Kidney Skinn arm use the device
- 70% of patients randomized to the device (Kidney Skinn) achieve a renal allograft surface temperature of <5C for the duration of the vascular anastomosis.
Measured: 2 years
Secondary outcomes (4)
Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care
Delayed Graft function as defined by the need for dialysis in the first 7 post operative days
Measured: 7 days
Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups
Urine and serum biomarkers for ischemia-reperfusion injury will be collected at specific key time points pre and post transplantation on all Part B trial participants. Specifically, urine and serum samples for unique markers of kidney injury (KIM-1 \& NGAL), inflammation (TNFR1, MCP-1) and fibrosis (suPAR, YKL 40).
Measured: 7 days
Serum creatinine level at discharge from initial hospitalization for transplantation
Local laboratory serum creatinine drawn per standard of care on all renal transplant recipients on day of discharge
Measured: 5-7 days
Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)
For each surgery, K-type 30 gauge thermocouples (each less than 0.25mm in external diameter) will be used in the renal allograft at a depth of 5 mm and 15 mm. This will be to measure surface (cortical) and core (medullary) temperatures, respectively.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Oct 2023 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization (Part B, 40 patients). This will be preceded with a single series of 5 consecutive patients (Part A).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Skinner
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Thomas Skinner, Nova Scotia Health Authority
- Investigators
- Thomas Skinner, Principal investigator, Nova Scotia Health AuthorityKarthik Tennankore, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166460
- Sponsor's protocol ID
- 1026704
- Acronym
- QuitWIT
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
- ClinicalTrials.gov ID
- NCT05166460
- Acronym / sponsor ID
- QuitWIT / 1026704
- Keywords
- kidney, transplant, warm ischemia time, delayed graft function, vascular anastomosis, renal hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Thomas SkinnerUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 22 Dec 2021 (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.
Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.
Detailed description
Warm ischemia can damage a renal allograft in many different ways often leading to early failure of the kidney transplant and sometimes even death of the transplant recipient. For this reason every effort is made to keep the allograft cold during the removal and transportation, and protocols have been developed to ensure this. Although kidneys are kept below 5°C during transportation, they re-warm rapidly during the transplant surgery. On average, kidneys are exposed to 40 or more minutes of dangerously warm temperatures during transplant surgery.
To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.
The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.
A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 1:1 randomization (Part B, 40 patients). This will be preceded with a single series of 5 consecutive patients (Part A).
| Arm | Type | Receives |
|---|---|---|
| Surgery utilizing the Kidney Skinn cooling device | Experimental | Device: Kidney cooling deviceAll patients in Part A, and those randomized to the Kidney Skinn arm in Part B, will receive transplant surgery in the traditional fashion with the exception that the renal allograft will be placed in the cooling device at the initiation of the vascular anastomosis. Cold saline irrigation flowing through the device will be used to maintain renal hypothermia for the duration for the vascular anastomosis. After the vascular clamps are released, the device will be removed. |
| Standard transplant surgery practice | No intervention | –Standard transplant surgery per site practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age at time of transplant
- Slated to receive a single cadaveric organ
- Donor declared by traditional neurological determination of death (NDD)
- Standard criteria donor (SCD) or Extended criteria donor (ECD)
- Consent obtained prior to the transplant operation
Key exclusion criteria (4 listed)
- Living donor (LD)
- Donor after cardiocirculatory death (DCD)
- Highly sensitized patients (those with Panel-reactive antibody or PRA >80%)
- Recipient of a previous kidney transplant
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 |
|---|---|---|
| Kidney cooling deviceAlso: Kidney Skinnrenal cooling device designed to maintain renal hypothermia at or below 5ºC for 60 minutes. | Device | Surgery utilizing the Kidney Skinn cooling device |
Primary outcome
Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)
Time frame: 6 months
The Kidney Skinn cooling device can be utilized during vascular anastomosis, and the ability of the device to maintain surface and core temperatures of transplant kidneys at <5ºC for the duration of the vascular anastomosis.
Part B: To determine the feasibility of a trial using the Kidney Skinn cooling device to usual care to ameliorate warm ischemia time during kidney transplantation
Time frame: 2 years
Feasibility Outcomes will include the following: 1. Ability to randomize >60% of eligible patients 2. >75% of patients randomized to the Kidney Skinn arm use the device 3. 70% of patients randomized to the device (Kidney Skinn) achieve a renal allograft surface temperature of <5C for the duration of the vascular anastomosis.
4 secondary outcomes
Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care
Time frame: 7 days
Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups
Time frame: 7 days
Serum creatinine level at discharge from initial hospitalization for transplantation
Time frame: 5-7 days
Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No. This is a pilot study
Related trials for Kidney Transplant; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
Thomas Skinner principal investigator
Nova Scotia Health Authority
Karthik Tennankore principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney cooling device in people with Kidney Transplant; Complications and Delayed Graft Function, run by Thomas Skinner at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Skinner (902-425-3940, tomaaskinner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 21 Apr 2023.