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Active Not RecruitingNCT07289906

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMass change in serum albuminstudy 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

Timeline

Start date
2025-09-28
Primary completion
2026-09-28
Completion
2026-09-28
First posted
2025-12-17
Last updated
2025-12-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07289906. Inclusion in this directory is not an endorsement.