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临床试验/NCT05666895
NCT05666895尚未招募不适用

Role of CBC as a Prognostic Marker for DKA Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1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
100
试验地点
1
主要终点
Measure of inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) changes in DKA patients and affection of these changes on inflammation development and prognosis of DKA

研究概览

简要总结

  1. To evaluate that change of platelet-to-lymphocyte Ratio affect the duration of hospital stay and mortality rate of DKA patients
  2. To assess the impact of red blood cell distribution width (RDW) on the prognosis of diabetic ketoacidosis patients
  3. To evaluate the changes in hematological parameters (RBCs,Hct,Hb,MCV,PLT,WBCs) and their correlations with acidosis level and dehydration during ketoacidosis treatment

详细描述

Diabetes Mellitus (DM) is a serious threat to global health with an increasing prevalence and incidence rates,The number of people who had DM was 463 million in 2019,and according to international diabetes federation [IDF] this number will have reached 700 million in 2045 (1).

One of the most serious complication of DM is diabetic ketoacidosis (DKA) which is a life-threatening acute copmlication of diabetes mellitus [DM], [DKA] occur in patients with both type 1 and type 2 diabetes, for which type 1 and type 2 diabetes is responsible for 66% and 34% patients respectively (2,3).

Despite the development of improved treatment, DKA remains at a high incidence of recurrence and a leading cause of mortality among patients with DM, resulting in an elevated burden for patients,hospitals,and healthcare providers(4,5).

As a systemic metabolic disease,DKA has been reported to be associated with the inflammatory response of the hyperglycaemic state(6,7). the inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) play an important role in the development of inflammation and affect prognosis of DKA One of the most things that affected by diabetic ketoacidosis is hydration status, As DKA can cause dehydration and some complications may result from that such as cerebral edema,coma or even death(8,9).

there are many methods to estimate the hydration status such as clinical dehydration scale(CDS), hematological parameters (RBC, Hct , Hb MCV, PLT ,WBC) which are used as an alternative approach to estimate the extent of dehydration in DKA patients(10,11).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include patient with type 1 or type 2 DM, patients > 18 yrs, DKA patients (based on the criteria of the American Diabetes Association (ADA): plasma glucose > 13.9 mmol/l (250 mg/dL), arterial pH < 7.3 and a bicarbonate level <18 mEq/l, with ketonuria)

排除标准

  • The study will exclude patients <18 yrs , patients with history of hematological disease like(leukemia,hemophilia,thalassemia,sickle cell anaemia,polycythemia vera),patients with history of renal or cardiac or hepatic disease)

结局指标

主要结局

Measure of inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) changes in DKA patients and affection of these changes on inflammation development and prognosis of DKA

时间窗: Baseline

the inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) play an important role in the development of inflammation and affect prognosis of DKA and and changes in these markers also affect duration of hospital stay and mortality rate in DKA patients

次要结局

  • Hematological parameters (RBC, Hct , Hb MCV, PLT ,WBC) which are used as an alternative approach to estimate the extent of dehydration in DKA patients(Baseline)

研究者

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

Mohamed Mamdouh Tawfik Abdelaleem

Resident

Assiut University

研究点 (1)

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