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临床试验/NCT05147818
NCT05147818Unknown不适用

Risk Factors for Acute Kidney Injury in Diabetic Patients

Assiut University0 个研究点目标入组 400 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
Identify risk factors for Acute kidney injury in diabetic patients

研究概览

简要总结

incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients.

详细描述

The incidence and prevalence of diabetes mellitus (DM) have increased over the last 20 years. The defining feature of diabetes mellitus (DM) is the presence of hyperglycaemia . mostly due to the progressively increasing prevalence of obesity and the metabolic syndrome, Current prevalence of DM worldwide is estimated to be about 390 million people . The Cardiovascular complications increase morbidity and mortality in diabetic patients. About 40% of end-stage renal disease on regular dialysis are diabetic . Acute kidney injury (AKI) Is a fundamental problem in hospitalized patients; its incidence has been reaching 20% in middle-Europe . About 50% of patients presented with AKI are found to be diabetic ; which may indicate a direct relationship between the two conditions. In 2012, a clinical practice guideline published by Kidney Disease: Improving Global Outcomes (KDIGO) provided a unifying definition and staging system for AKI . On the other hand, incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients. We aim in this study to identify the most common risk factors for AKI in diabetic patients and how those risk factors affect morbidity and mortality in patients with DM who developed AKI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Inclusion criteria for the cases :
  • 200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition & Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume <0.5 mL/kg/h for 6 h.
  • KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output <0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output <0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients <18 years, decrease in eGFR to <35 mL/min per 1.73 m2 / Urine output <0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .
  • Inclusion criteria for matched controls 200 Diabetic patients of 18 year and older with no AKI (either type 1or 2)

排除标准

  • Exclusion criteria for cases and controls:
  • Non-Diabetic patients with AKI
  • Diabetic patients with:
  • HBS Ag, HCV, HIV
  • Active Lupus
  • Active Malignancy
  • Acute or Chronic Liver Disease
  • Acute poisoning

结局指标

主要结局

Identify risk factors for Acute kidney injury in diabetic patients

时间窗: 2 years

Identify risk factors for Acute kidney injury in d iabetic patients

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

Shimaa Salah Ali

Principal investigator

Assiut University

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