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临床试验/NCT07645599
NCT07645599尚未招募不适用

Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function

Roderick Tan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

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.

详细描述

Specific Aim 1: Utilize super-resolution ultrasound (SRU) to analyze tiny blood vessels in transplanted kidneys under very detailed imaging and evaluate kidney allografts and predict post-transplantation function.

Delayed graft function (DGF) is a common complication that can happen soon after a kidney transplant and may lead to longer recovery times and other health problems. Kidney biopsies are typically required to find the cause, which are invasive procedures. Current imaging tests cannot clearly show the tiny blood vessel changes inside the transplanted kidney that may contribute to the development of DGF.

Hypothesis: Investigators hypothesize that SRU can noninvasively predict DGF outcomes by measuring changes in the structure of tiny kidney blood vessels and the blood flow within them.

Approach:

Aim 1a: Compare SRU-derived measures of renal microvasculature-including microvascular density, tortuosity, and cortical perfusion-between patients who develop DGF and those with uncomplicated graft function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For stage 1 of the study:
  • 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)
  • For stage 2 of the study
  • 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)

排除标准

  • Inability to provide informed consent
  • Pregnant woman
  • Breastfeeding women
  • Hypersensitivity to perfluten lipid microsphere and components including polyethylene glycol (PEG)
  • Unstable cardiopulmonary condition (acute myocardial infarction, acute coronary artery symptoms, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
  • Known history of cardiac shunts
  • Patients who have known sickle cell disease or trait

研究者

发起方
Roderick Tan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Roderick Tan

Associate Professor

University of Pittsburgh

研究点 (1)

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