Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease

This observational study will collect clinical and laboratory information from hospitalized patients with chronic kidney disease to identify diabetes mellitus and selected metabolic findings during hospitalization

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Chronic Kidney Disease Patients
• Intervention / Treatment: Behavioral: Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi

Detailed Description

Hospitalized adult patients with chronic kidney disease will be included in this observational study. Information routinely recorded during hospitalization will be collected. This information will include the presence of diabetes mellitus and laboratory values related to blood glucose levels, electrolyte levels, and acid base balance. No study related interventions will be performed.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mohamed Mahmoud Rashad, Master Degree; Phone Number: 01153640803; Email: mohammed_rashad_post@med.sohag.edu.eg
• Study Contact Backup: Name: Mahmoud Ibrahim Yousef, Associate Professor; Phone Number: 01065964083; Email: mahmoudibrahim@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital
    • Contact: Mohamed Mahmoud Rashad, Master Degree; Phone Number: 01153640803; Email: mohammed_rashad_post@med.sohag.edu.eg
    • Contact: Mahmoud Ibrahim Yousef, Associate Professor; Email: mahmoudibrahim@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A) Inclusion criteria:

• Age ≥18 years.
• Known CKD (baseline eGFR <60 mL/min/1.73 m² for ≥3 months) OR documented CKD stage 3-5 by prior records.
• Hospitalized for any medical reason.
• Consent provided.

B) Exclusion criteria:

• Acute single episode of reversible AKI with previously normal renal function (no established CKD).
• Admission for palliative care /expected survival <24 hours.
• Pregnancy.

C) Patient groups (for analysis):

Diabetes status:

• Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission).
• Non-diabetic CKD.

D) Subgroups / Diabetic patient group: Metabolic derangement categories

1. Acute hyperglycemia

   • Diabetic ketoacidosis (DKA) /hyperosmolar hyperglycemic state (HHS)
   • Patients without DKA or HHS

2. Hypoglycemia

   • Hypoglycemia: any blood glucose <70 mg/dL (and severe <40 mg/dL).
   • Without Hypoglycemia episodes
3. Metabolic acidosis arterial or venous HCO₃- <20 mmol/L or pH <7.35 with anion gap >12 as appropriate.

Description

Inclusion Criteria:

• Age greater than or equal to 18 years
• Known chronic kidney disease, defined as baseline estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters for at least 3 months, or documented chronic kidney disease stage 3 to 5 by prior medical records
• Hospitalized for any medical reason
• Consent provided

Exclusion Criteria:

• Acute single episode of reversible acute kidney injury with previously normal renal function (no established chronic kidney disease)
• Admission for palliative care or expected survival less than 24 hours
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD

Behavioral: Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi; Primary aim; To assess the frequency of diabetes mellitus among hospitalized CKD patients.; To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosis/ hyperosmolar states, metabolic acidosis, dyslipidemia, electrolyte imbalance) in diabetic CKD patients. Secondary aim 1. To evaluate the association between diabetes and diabetes-related metabolic derangements in-hospital adverse outcomes (major cardiovascular events, ICU admission, length of stay, infection rate, need for dialysis and mortality) among hospitalized patients with CKD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Hospital Mortality	Patient death from any cause occurring during the hospitalization period	From admission until hospital discharge, assessed over a 6-month study enrollment period.
New Requirement for In-Hospital Renal Replacement Therapy	Initiation of dialysis in a patient who was not receiving renal replacement therapy at the time of hospital admission	From admission until hospital discharge, assessed over a 6-month study enrollment period.
Incidence of a Major In-Hospital Cardiovascular Composite Event	A composite outcome defined as the first occurrence of any of the following during the hospitalization: myocardial infarction, stroke, or new-onset heart failure requiring inotropic support or mechanical ventilation	From admission until hospital discharge, assessed over a 6-month study enrollment period.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med--25-12-5MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No