Risk Factors for Acute Kidney Injury in Diabetic Patients

Assiut University

Status: Unknown

Conditions: Diabete Mellitus

Treatments: Other: CBC ,renal function tests , fundus Examination

Study type: Observational

Funder types: Other

Identifiers

NCT05147818

SSA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria for cases and controls:

1. Non-Diabetic patients with AKI

2. Diabetic patients with:

   • HBS Ag, HCV, HIV
   • Active Lupus
   • Active Malignancy
   • Acute or Chronic Liver Disease
   • Acute poisoning

Trial design

400 participants in 2 patient groups

Cases

Description:

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 .

Treatment:

Other: CBC ,renal function tests , fundus Examination

Controls

Description:

200 Diabetic patients of 18 year and older with no AKI (either type 1or 2) Matched to controls in age ,sex