Measurement of Mass Change in Serum Albumin Compared to Serum Lactic Acid as Predictive Tool for Sepsis Prognosis in Non Surgical ICU Patients

This study aims to assess the reliability of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients

Study Overview

• Status: Active, not recruiting
• Conditions: Prognosis Prediction of Sepsis in Icu Patients
• Intervention / Treatment: Diagnostic test: Mass change in serum albumin

Detailed Description

This study explores the prognostic value of mass change in serum albumin compared to serum lactic acid levels in non-surgical ICU patients with sepsis. While serum lactate is an established marker of tissue hypo-perfusion and a predictor of sepsis outcomes, serum albumin is less frequently used for dynamic monitoring, although it is known to correlate with severity and mortality

Measurements:

Data Collection:

A-Baseline Data on ICU Admission:

1. Demographics: age, sex
2. Comorbidities (e.g., diabetes, hypertension, chronic kidney disease)
3. Initial hemodynamic parameters (BP-HR-SO2-ECG-UOP-TEMP-RR)

4. diagnosis of sepsis involves recognising signs of infection plus organ dysfunction according to SSC and sepsis -3

   A- Search about source of infection by:

   • History of present illness about main complain.
   • clinical examination
   • investigation a. labs (CBC (containing TLC and platlets), CRP, Procal, BloodGases (containing serum lactate), Urea, serum Creatinine, TotaL bilirubin, Urine Analysis, Pan culture, AST, ALT) b-imaging (chest x.ray) B- organ dysfunction Defined as increase increase in SOFA (Sequential Organ Failure Assessment) score >=2 points from baseline.

   SOFA Score range:

   0-6: low risk of organ failure 7-12: moderate risk >12: high risk of mortality

5. initial reading of serum albumin in admission (T0)
6. initial reading of albumin creat ratio (ACR)as tool for measuring albumin in urine Patients with severe albuminuria will be excluded from the study

Daily measurements:

1. Average of 24 HR (BP, HR, SO2, TEMP, RR,)
2. CBC, CRP, serum urea, serum creatinine, Total bilirubin, serum Albumin, blood gases (containing serum lactate)

3-24HR Fluid balance.

• ACR will be measured every 3days during study to predict any abnormal increase in albumin loss in urine

C- Daily recordings:

1. SOFA score.
2. mass changes in serum albumin (T0-T1, T1-T2, T3-T2……...ETC).
3. serum lactate.
4. vasopressor use.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Elabasya
    • Cairo, Elabasya, Egypt
      • Hospitals ofAin shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort study is planned, aiming to enroll a minimum of 40 patients. The sample size calculation is based on findings from Mahashabde et al. (2024), which reported that the predictive accuracy of serum lactase for septic shock at admission had an AUC ROC of 0.96, while serum albumin had an AUC ROC of 0.323. The anticipated incidence of septic shock is 42%, as reported in the EPIC ill study (2019). The sample size was calculated to achieve 100% statistical power with a significance level (alpha) of 0.05.

Description

Inclusion Criteria:

• Adults aged ≥18 year 70 years. Diagnosis of sepsis according to survival sepsis campaign(SSC). Patients admitted for medical (non-surgical) conditions.

Exclusion Criteria:

• Chronic liver disease or cirrhosis. Hyperalbuminuria (ex: nephrotic syndrome, nephritic syndrome). Terminal illness with an expected survival of less than 24 hours. Refusal or inability to obtain informed consent from patients or their care givers.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)	Knowing Which is more accurate in predicting the prognosis of sepsis between mass change in serum albumin and serum lactic acid in non surgical icu patients	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of vasopressor use and its correlation to prognosis of sepsis.	If long duration of using vasopressor correlate with prognosis of sepsis	12months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Alaa E Mohamed Hassen, Prof, Department of anesthesia ,Intensive Care and pain management

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MD241/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO