BAR As a Mortality Predictor in Septic AKI

Completed

• Conditions: Acute Kidney Injury; Sepsis

• Registration Number: NCT06584149
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

Detailed Description

A complete medical history will be obtained from all patients including age, sex, comorbidities, cause of sepsis, and SOFA and APACHE II scores at admission.

Blood samples will be collected within 24 hours of AKI diagnosis for analysis of Blood Urea Nitrogen (BUN) and serum Albumin levels.

Blood Urea Nitrogen to serum Albumin ratio (B/A) will be calculated by dividing the BUN of a patient by their serum Albumin levels.

Laboratory parameters also will include pH, lactate (Lac), base excess (BE), hemoglobin (Hb), platelet (PLT) count, white blood cell (WBC) count, bilirubin, hematocrit (HCT), creatinine (Cr), serum sodium (Na), serum potassium (K), serum calcium (Ca), serum magnesium (Mg), triglyceride (TG), aspartate aminotransferase (ALT), alanine aminotransferase (AST), prothrombin time (PT), and activated partial thromboplastin time (APTT) values.

Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

Study population will be divided into survival and non-survival groups based on their 30-day survival status

Study Timeline

• Study Start: 2023-09-25
• Primary Completion: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-24
• Study First Submitted QC: 2024-09-01
• Study First Posted: 2024-09-04
• Study Completion: 2024-09-25
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. 18 - 60 years of age
2. Fulfilled the diagnostic criteria of Sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (SOFA) score of 2 or higher)
3. Developed AKI during hospitalization according to Kidney Disease: Improving Global Outcomes (KDIGO) guideline

Exclusion Criteria

1. ICU length of stay<24 h
2. AKI occurred before current hospital admission.
3. AKI is supposed to be secondary to causes other than sepsis.
4. Receiving renal replacement therapy at the time of admission.
5. Diagnosis with chronic kidney disease.
6. Diagnosis with liver failure.
7. Pregnant or lactating.
8. There was insufficient data for analysis.
9. Patients who had received Human serum Albumin infusion 3 days before ICU admission.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	30 days	number of cases of mortality

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation	30 days	number of participants who needed mechanical ventilation
stage-3 AKI	30 days	number of participants who developed stage-3 AKI
renal replacement therapy	30 days	number of participants who needed renal replacement therapy
septic shock	30 days	number of participants who developed septic shock
length of ICU stay	30 days	length of ICU stay in days

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbassia, Egypt