Risk Factors for Acute Kidney Injury in Diabetic Patients

November 27, 2021 updated by: Shimaa Salah Ali, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients aged from 18 year and older Diabetic patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Laboratory investigations
Other Names:
  • ECG
Controls
200 Diabetic patients of 18 year and older with no AKI (either type 1or 2) Matched to controls in age ,sex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify risk factors for Acute kidney injury in diabetic patients
Time Frame: 2 years
Identify risk factors for Acute kidney injury in d iabetic patients
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 27, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 27, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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