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Risk Factors for Acute Kidney Injury in Diabetic Patients

NCT ID: NCT05147818

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabete Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 .

CBC ,renal function tests , fundus Examination

Intervention Type OTHER

Laboratory investigations

Controls

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

No interventions assigned to this group

Interventions

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CBC ,renal function tests , fundus Examination

Laboratory investigations

Intervention Type OTHER

Other Intervention Names

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ECG

Eligibility Criteria

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Inclusion Criteria

\-


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 .

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Salah Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 25537714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26670418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23619194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26251707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33547417 (View on PubMed)

Other Identifiers

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SSA

Identifier Type: -

Identifier Source: org_study_id