Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT05147818
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05147818
Study Brief:
Protocol Section:
NCT05147818