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临床试验/NCT01451931
NCT01451931已完成4 期

Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic

University of California, San Francisco30 个研究点 分布在 1 个国家目标入组 2,776 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
2,776
试验地点
30
主要终点
High Risk Diagnosis With Complication

研究概览

简要总结

This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.

详细描述

This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men or women = or >18 but <76 years of age presenting with acute renal colic
  • Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

排除标准

  • children < 18 years old
  • elderly patients > or = 76 years old
  • pregnancy or planning pregnancy
  • Morbid obesity (>285 pounds in men, >250 pounds in women)
  • patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
  • history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

结局指标

主要结局

High Risk Diagnosis With Complication

时间窗: 30 days from baseline

Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.

Cumulative Radiation Exposure

时间窗: Baseline plus 6 months post-baseline

次要结局

  • ED Length of Stay(Baseline visit excluding hospitalization)
  • Return Visits to ED or Hospital(6 months post-baseline)
  • Accuracy for Stones by Arm(Up to 6 month follow-up for stone passage)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (30)

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Study of Tomography of Nephrolithiasis Evaluation | 临床试验