Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function

ConditionsEnd Stage Chronic Renal Failure Renal Transplant Microvascular Changes Microvascular Circulation

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorRoderick Tan

About this trial

This pilot study is testing a new ultrasound imaging method called Super-Resolution Ultrasound (SRU) to look at blood flow and tiny blood vessels in transplanted kidneys in very detailed images after kidney transplant surgery. The goal is to see whether changes in the kidney's small blood vessels can help predict how well the transplanted kidney will work early after transplant, including whether delayed graft function may occur.

Investigators hope this technique can become a safe, noninvasive way to evaluate transplanted kidneys without needing as many invasive biopsies. It may also help doctors better assess donor kidneys at higher-risk of suboptimal functioning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

We will enroll patients ≥18 years of age

Patients who received a kidney transplant 2a. Patients requiring dialysis in the first 14 days after transplant 2b. Patients with working allografts not requiring dialysis (control group)

We will enroll patients at least 18 years of age or older

Patients who received a kidney transplant 2a. Patients who received kidney transplants from low KDPI kidneys (KDPI < 35) 2b. Patients who received kidney transplants from high KDPI kidneys (KDPI > 75)

Disqualifiers

BMI > 40

Inability to provide informed consent

Pregnant woman

Breastfeeding women

Trial population

Adult patients with end stage kidney disease who are receiving deceased donor kidney allograft transplants who meet the inclusion and exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ultrasound contrast agent (Contrast-enhanced ultrasound)
Diagnostic test
Super-resolution ultrasound using lipid microsphere contrast
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)
Drug
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Lumason® contrast agent
Drug
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
DEFINITY®
Drug
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.

Treatment groups

40 Participants

are divided into 4 treatment groups

Group A: High KDPI4 interventions

Group B: Low KDPI4 interventions

Group C: Delayed Graft Function4 interventions

Group D: Non-delayed Graft Function4 interventions

Trial outcomes

Primary outcomes

Kidney vascularity

Assessment of total renal vascularity and measures of perfusion. Images obtained with the kidney ultrasound will be analyzed for total number of blood vessels and blood perfusion detected in different regions of the kidney.

Time frame

Less than 30 minutes

Secondary outcomes

Kidney blood vessel tortuosity

While the total number of blood vessels may differ between subjects, it is also possible that the number of blood vessel branches may be different.

Time frame

up to 30 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roderick Tan

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov

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