跳至主要内容
临床试验/CTRI/2025/10/096353
CTRI/2025/10/096353尚未招募不适用

Correlation of urinary KIM-1 and NAG with Serum Creatinine for early detection of Acute kidney injury in Pediatric cancer patients receiving chemotherapy-A one year cross sectional study in Belagavi

Dr Gouri M Patil1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To correlate the efficacy of selected urinary biomarker’s i.e. urinary KIM-1 and urinary NAG with serum creatinine in the early detection of Acute Kidney Injury (AKI) among pediatric cancer patients receiving chemotherapy agents.

研究概览

简要总结

Acute Kidney Injury AKI is a prevalent and serious condition associated with significant morbidity and mortality. It affects 30 to 50 percent of critically ill patients and those requiring renal replacement therapy have a mortality rate exceeding 50 percent. Among pediatric oncology patients AKI is a common complication affecting approximately 15 to 25 percent of patients. It can be caused by chemotherapeutic agents such as cisplatin methotrexate and ifosfamide as well as by sepsis dehydration and tumor lysis syndrome. Early detection of AKI is crucial to prevent progression to chronic kidney disease dialysis dependency and increased morbidity and mortality.

Currently serum creatinine is the most commonly used marker for detecting AKI. However it has significant limitations due to its low sensitivity and specificity. Its levels can be influenced by various factors including age sex muscle mass hydration status and dietary intake. Moreover it tends to rise only after substantial kidney injury has occurred and often with a delay.

Recent research has highlighted the potential of novel urinary biomarkers such as kidney injury molecule-1 uKIM-1 and N-acetyl-beta-D-glucosaminidase uNAG in identifying early tubular damage before changes in serum creatinine occur. These biomarkers can detect subclinical forms of AKI thereby allowing for earlier intervention.

The aim of our study is to evaluate the incidence of AKI including subclinical AKI in pediatric oncology patients undergoing chemotherapy and to assess the diagnostic utility of urinary biomarkers uKIM-1 and uNAG compared to serum creatinine in the early detection of AKI.

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 aged 1- 18 years diagnosed with malignant diseases and receiving chemotherapy agents with renal route of excretion causing Acute Kidney Injury like (ex: methotrexate, cisplatin, carboplatin etc.) and Chemotherapy agents causing with non-renal route of excretion causing Acute Kidney Injury (Vincristine, Cytarabine, Etoposide etc.
  • ) at KLE Hospital, Belagavi.

排除标准

  • Pre-existing CKD Structural renal anomalies.
  • Post – Nephrectomy Renal tumors.
  • Who have received nephrotoxic antibiotics greater than 10 days.
  • Administration of contrast medium in the previous 14 days.
  • Incomplete data or refusal of consent.

结局指标

主要结局

To correlate the efficacy of selected urinary biomarker’s i.e. urinary KIM-1 and urinary NAG with serum creatinine in the early detection of Acute Kidney Injury (AKI) among pediatric cancer patients receiving chemotherapy agents.

时间窗: 0 hours and 24 hours

次要结局

  • 1 To determine the risk factors of Acute Kidney Injury in pediatric oncology patients receiving chemotherapy(2 To evaluate the diagnostic timeline of biomarkers like KIM1 And NAG at baseline 0 hour before chemotherapy And 24 hours post chemotherapy with elevation of serum creatinine)

研究者

发起方
Dr Gouri M Patil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gouri M Patil

Jawaharlal Nehru Medical College

研究点 (1)

Loading locations...

相似试验

Checking for early kidney problems in children with... | 临床试验