Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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 |
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.