Risk Factors for Acute Kidney Injury in Diabetic Patients

NCT05147818 | Unknown

• 1 other identifier: SSA
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (1)

• Identify risk factors for Acute kidney injury in diabetic patients

  Identify risk factors for Acute kidney injury in d iabetic patients

  2 years

Study Arms (2)

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 .

Other: CBC ,renal function tests , fundus Examination

Controls

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

Interventions

CBC ,renal function tests , fundus Examination OTHER

Laboratory investigations

Also known as: ECG

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients aged from 18 year and older Diabetic patients.

You may qualify if:

• 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 .

You may not qualify if:

• Non-Diabetic patients with AKI
• Diabetic patients with:
• HBS Ag, HCV, HIV
• Active Lupus
• Active Malignancy
• Acute or Chronic Liver Disease
• Acute poisoning

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.

  PMID: 25537714 BACKGROUND

• Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015 Dec 15;10:172. doi: 10.1186/s13012-015-0354-6.

  PMID: 26670418 BACKGROUND

• Mima A. Diabetic nephropathy: protective factors and a new therapeutic paradigm. J Diabetes Complications. 2013 Sep-Oct;27(5):526-30. doi: 10.1016/j.jdiacomp.2013.03.003. Epub 2013 Apr 22.

  PMID: 23619194 BACKGROUND

• Bienholz A, Wilde B, Kribben A. From the nephrologist's point of view: diversity of causes and clinical features of acute kidney injury. Clin Kidney J. 2015 Aug;8(4):405-14. doi: 10.1093/ckj/sfv043. Epub 2015 Jul 9.

  PMID: 26251707 BACKGROUND

• DeFronzo RA, Reeves WB, Awad AS. Pathophysiology of diabetic kidney disease: impact of SGLT2 inhibitors. Nat Rev Nephrol. 2021 May;17(5):319-334. doi: 10.1038/s41581-021-00393-8. Epub 2021 Feb 5.

  PMID: 33547417 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 7, 2021
• Study Start: December 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share