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NCT Number: NCT07289906

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospitals ofAin shams university

Cairo, Elabasya, Egypt

About this study

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:

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

  • initial reading of serum albumin in admission (T0)
  • 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:

  • Average of 24 HR (BP, HR, SO2, TEMP, RR,)
  • 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:

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mass change in serum albumin

Diagnostic Test

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

Other names: Serum lactate

Primary outcomes

  1. Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)

    Time frame: 12 months

    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

Secondary outcomes

  1. Duration of vasopressor use and its correlation to prognosis of sepsis.

    Time frame: 12months

    If long duration of using vasopressor correlate with prognosis of sepsis

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.