Bacterial and Host Genetic Risk Factors in Acute Pyelonephritis
Bacterial and Host Genetic Risk Factors That Predispose Children to Acute Pyelonephritis and Renal Scarring
研究概览
地位
条件
详细说明
研究类型
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Infants admitted to the inpatient ward at Children's National Medical Center for the treatment of a febrile urinary tract infection (see definitions) will be screened for inclusion into the research protocol.
UTIF: A UTIF will require the presence of
- (1) fever and/or symptoms consistent with UTI,
- (2) pyuria based on urinalysis, and
- (3) culture-proven infection with a single organism. Specifically, the study definition of UTIF will require:
- Fever: A documented temperature of at least 100.4 °F or 38°C, measured anywhere on the body either at home or at doctor's office.
Positive dipstick analysis: Pyuria on urinalysis (>10 WBC/mm3 (uncentrifuged specimen) OR >5 WBC/hpf (centrifuged specimen), OR >1+ leukocyte esterase on dipstick).
- Culture documentation of UTI: Evidence of bacteria (>5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen). Bag collected specimens will not be acceptable
Exclusion Criteria:
- Infants who do not conform to the above inclusion criteria and who have co-morbidities such as duplication abnormalities, diabetes mellitus, over weight status, anatomical defects of the urinary tract and neuropathic bladder dysfunction.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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With APN, With VUR, With Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and a renal scar on follow-up DMSA renal scan.
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With APN, With VUR, Without Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and NO renal scar on follow-up DMSA renal scan.
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With APN, without VUR, with Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan but who will NOT have VUR by VCUG; however they will have a renal scar on follow-up DMSA renal scan.
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With APN, Without VUR, Without Renal Scar
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will NOT have VUR by VCUG, NOR will they have a renal scar on follow-up DMSA renal scan.
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Without APN, With VUR
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also have VUR by VCUG.
They will not undergo a second DMSA scan since the first one is normal.
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Without APN, Without VUR
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also NOT have VUR by VCUG, NOR a renal scar on follow-up DMSA renal scan.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of acute pyelonephritis lesions
大体时间:< 72 hours after presentation with fever and positive urine culture
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Children under two years of age will undergo a 99m-Tc-DMSA renal scan for the detection of acute pyelonephritis lesions within 72 hours of presentation to the ED for evaluation of a fever and positive urine culture. Based on finding the characteristic lesions (such as preservation of the renal contour but with diminished photopenia. This outcome measure will be aggregated with other bacterial and host related risk factors in order to identify the salient ones that result in morbidity from bladder infection. |
< 72 hours after presentation with fever and positive urine culture
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of renal cortical scarring
大体时间:At least 6 months
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Since the lesions associated with acute pyelonephritis can resolve up to 6 months following infection, we will stress the importance of obtaining these delayed scans for the purpose of ascertaining whether the inflammation has resulted in a fixed lesion, termed a renal scar.
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At least 6 months
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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