跳至主要内容
临床试验/CTRI/2024/05/067307
CTRI/2024/05/067307招募中不适用

PROCALCITONIN AND D-DIMER: MARKERS FOR EARLY DIAGNOSIS OF ACUTE PYELONEPHRITIS IN CHILDREN WITH URINARY TRACT INFECTION AT TERTIARY CARE HOSPITAL

Jawaharlal Nehru Medical College KLE University Belagavi1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2024年5月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
49
试验地点
1
主要终点
To study that procalcitonin and d-dimer levels are elevated in children having acute pyelonephritis in comparison with children having cystitis

研究概览

简要总结

Urinary tract infection (UTI) is one of the most common bacterial infections in children that can      be associated with renal parenchymal injuries and late scars suggestive of Acute pyelonephritis (APN).

DMSA scan known as gold standard for detecting Acute Pyelonephritis has lot of limitations. It is expensive, not easily available, has risks for radiation exposure and failure to distinguish between old and new scars unless follow-up scan is done. Gold Standard for diagnosis of UTI is urine culture which is time consuming and yield contamination if sample is not taken properly.

The clinical diagnosis is also difficult, as both cystitis and acute pyelonephritis patients sometimes present with non-specific symptoms of UTI. Delay in diagnosis eventually leads to delay in treatment causing more damages to renal parenchyma; or outpatient abuse of unnecessary antibiotics which can lead to subsequent development of antibiotic resistance.

D-dimer and PCT level can be determined by venous blood samples that is generally available in all hospitals, therefore we sought to use them as an inflammatory marker in UTI for early diagnosis of Acute pyelonephritis.

PCT is a precursor of calcitonin, with negligible blood levels under normal circumstances which appears in blood in few hours after inflammation, that could determine early renal parenchymal injury and helps to diagnose and treat children in best time possible to prevent renal scar. A meta-analysis of 18 studies concluded that PCT>= 1.0ng/ml has highest diagnostic performance for differentiation of acute pyelonephritis from cystitis. Studies also showed that PCT can also predict UTI severity.

D-dimer is a fibrin degradation product which represents the activation of coagulation system which can increase in conditions involving inflammation. Studies have reported its significance as an inflammatory marker of UTI.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children from one to eighteen years of age with symptoms of urinary tract infection
  • Positive urine routine as defined as more than or equal to 8 pus cell per cubic millimeter in clean catch, midstream urine.

排除标准

  • Prior treatment with antibiotics.

结局指标

主要结局

To study that procalcitonin and d-dimer levels are elevated in children having acute pyelonephritis in comparison with children having cystitis

时间窗: This study will be conducted over a span of one year

次要结局

  • To determine the accuracy of procalcitonin & d dimer by correlating its raised levels with urine routine positivity(This study will be conducted over a span of one year)
  • To evaluate the ability of serum procalcitonin & d dimer to predict pyelonephritic changes as assessed by USG KUB(This study will be conducted over a span of one year)

研究者

发起方
Jawaharlal Nehru Medical College KLE University Belagavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Saumya Arun Verma

Jawaharlal Nehru Medical College, KLE University

研究点 (1)

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