Evaluation of High Dose Methotrexate Toxicity in Correlation With Blood Methotrexate Level and the Role of Cystatin C in Prediction of Acute Kidney Injury in Pediatric Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Role of Cystatin C in prediction of acute kidney injury
研究概览
简要总结
This study aims to:
- Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre.
- Role of methotrexate blood level in prediction of high dose methotrexate related toxicities.
- Role of Cystatin C as a predictor for acute kidney injury in high dose methotrexate related toxicities.
- Factors affecting outcome of high dose methotrexate related toxicities.
详细描述
It is a prospective observational study will be carried out on children receiving high dose methotrexate in Sohag Oncology Centre with one-year observation starting from January 2024.
All children receiving high dose methotrexate in Sohag Oncology Centre and fulfill the study inclusion criteria with one-year observation starting from January 2024. Informed consent will be taken from the parents/guardians.
A Prepared sheet to collect data related to this study that include:
- Socio-demographic data: e.g. age, sex, residence in addition to dose of MTX and tumor type.
- General and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations.
- Investigations: blood samples will be collected for CBC, Urea, Creatinine, ALT, AST, Methotrexate level and Cystatin C.
- Treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors.
- Outcome: complete recovery, residual effects, complications or death.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children admitted to Sohag Oncology Centre, age from 1 to 18 years
- •receive high dose methotrexate therapy equal to or more than 1 gm/m2 surface area.
排除标准
- •WBCs less than 1000 / microliter
- •Platelet count less than 50000 / microliter
- •Renal affection
- •Hepatic affection
- •Respiratory affection
- •Diabetes mellitus
- •Cardiovascular disease
结局指标
主要结局
Role of Cystatin C in prediction of acute kidney injury
时间窗: Baseline
Venous samples will be collected about 3 milliliters under complete aseptic condition then centrifuged then the level of Cystatin C will be measured and will be used as abiomarker to detect acute kidney injury associated with high dose methotrexate related toxicities We will see if the test could predict occurrence of acute kidney injury before it happens or not
Role of methotrexate blood level in prediction of methotrexate related toxicities
时间窗: baseline
Venous blood will be collected under complete aseptic condition about 5 milliliters to measure serum methotrexate level using drug analyzer then the level of methotrexate will be used as apredictor to identify high dose methotrexate related toxicities in pediatric malignancies We will see if the test could predict the occurrence of toxicities before it happens or not
次要结局
未报告次要终点
研究者
Hosam Hasan Khalaf
assistant lecturer
Sohag University