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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07289906
Enrollment
40
Registered
2025-12-17
Start date
2025-09-28
Completion date
2026-09-28
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prognosis Prediction of Sepsis in Icu Patients

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.

Interventions

DIAGNOSTIC_TESTMass 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)12 monthsKnowing 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

Secondary

MeasureTime frameDescription
Duration of vasopressor use and its correlation to prognosis of sepsis.12monthsIf long duration of using vasopressor correlate with prognosis of sepsis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026