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

NCT ID: NCT07289906

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2026-09-28

Brief Summary

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

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.

Conditions

Prognosis Prediction of Sepsis in Icu Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mass change in serum albumin

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Serum lactate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alaa E Mohamed Hassen, Prof

Role: STUDY_DIRECTOR

Department of anesthesia ,Intensive Care and pain management

Locations

Hospitals ofAin shams university

Cairo, Elabasya, Egypt

Countries

Egypt

Other Identifiers

MD241/2025

Identifier Type: -

Identifier Source: org_study_id