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临床试验/NCT06143098
NCT06143098尚未招募不适用

Some Hematological Profile in Children With Chronic Kidney Disease

Assiut University0 个研究点目标入组 102 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
主要终点
descreption and observation in Complete blood count parameters in children with CKD

研究概览

简要总结

This study is asses the hematological changes in children with chronic kidney disease stage 3 to 5 including

  • Complete blood picture
  • Coagulation profile (PT, PC, PTT)
  • Iron study

详细描述

Chronic kidney disease (CKD) is a major public health issue with an increasing incidence and prevalence worldwide. In CKD, hematological parameters are influenced, it is associated with high morbidity and mortality rates, but there have been very few studies on the hematological profile of children with chronic kidney disease, on follow-up in general, and particularly among chronic kidney disease patients(Melaku.,et al 2022).

CKD is defined by the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2, it can last for 3 months or longer, regardless of the cause. Chronic kidney disease (CKD) is recognized as a major non-communicable disease in children. (Inker.,et al2014).

CKD is classifies it into 6 categories based on glomerular filtration rate (G1 to G5 with G3 split into 3a and 3b). It also includes the staging based on three levels of albuminuria (A1, A2, and A3), with each stage of CKD being sub-categorized according to the urinary albumin-creatinine ratio in (mg/gm) or (mg/mmol) in an early morning "spot" urine sample.( Inker,.et al 2012)

The 6 categories include:

  • G1: GFR 90 ml/min per 1.73 m2 and above
  • G2: GFR 60 to 89 ml/min per 1.73 m2
  • G3a: GFR 45 to 59 ml/min per 1.73 m2
  • G3b: GFR 30 to 44 ml/min per 1.73 m2
  • G4: GFR 15 to 29 ml/min per 1.73 m2
  • G5: GFR less than 15 ml/min per 1.73 m2 or treatment by dialysis The three levels of albuminuria include an albumin-creatinine ratio (ACR)
  • A1: ACR less than 30 mg/gm (less than 3.4 mg/mmol)
  • A2: ACR 30 to 299 mg/gm (3.4 to 34 mg/mmol)
  • A3: ACR greater than 300 mg/gm (greater than 34 mg/mmol). (Inker.,et al2014). hematological parameters such as white blood cell (WBC) include total leukocyte and differential counts, platelet (PLT), and red blood cell (RBC). Parameters, Kidney function ,electrolytes such as Na,k,ca and liver function bleeding time, and pro-thrombin time, are usually affected in CKD . These are common in CKD due to erythropoietin deciency and other factors such as increased hemolysis, suppression of bone marrow erythropoiesis, hematuria, and gastro intestinal blood loss. (George.,et al2015).

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Childen aged 1:18 years with chronic kidney disease stage 3 to 5 (estimated glomerular filteration rate >60 ml/min per 1.73 m2).

排除标准

  • Children >1year.
  • Children with chronic kidney disease in stage 1 and
  • Children with liver disease.
  • Children known blood disorder rather than anemia.
  • Children with malignancy.
  • Children with recent bleeding tendancy.

结局指标

主要结局

descreption and observation in Complete blood count parameters in children with CKD

时间窗: baseline

asses changes in Complete blood count parameter in children with chronic kidney disease stage 3 to 5

descreption and observation in iron profile in children with CKD

时间窗: baseline

asses changes in serum ferritin ,serum iron, Trans ferritin saturation and Total iron binding capacity in children with chronic kidney disease stage 3 to 5

descreption and observation in coagulation profile in children with CKD

时间窗: baseline

asses changes in prothrombin time, prothrombin concentration, partial thromboplastin time,and international normalized ratio in children with chronic kidney disease stage 3 to 5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeinab Othman AbdelGaleel

principal investigator

Assiut University

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