Serum Albumin Ratios Can Improve Sepsis Mortality Prediction

NCT06640504 | Completed

• 1 other identifier: Rc 4-9-2024
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis remains a leading cause of mortality in hospitalized patients, despite advancements in critical care. Existing clinical scores for predicting sepsis outcomes often lack generalizability and complexity, hindering accurate risk assessment and timely intervention. This study aimed to evaluate the prognostic performance of serum albumin ratios to C-reactive protein (CRP), procalcitonin (PCT), and lactate in predicting 28-day morbidities and mortality in sepsis patients admitted to surgical ICUs. By incorporating these albumin ratios into clinical decision-making, we hypothesized that clinicians could more accurately identify patients at high risk of adverse outcomes and tailor treatment strategies accordingly.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• The proportion of patients reported having at least a 50% lower risk of mortality in surgical ICU (measured by the APACHE II Scale) in correlation with blood biomarkers ratio.

  The diagnostic value of blood biomarkers ratio as lactate-to-albumin ratio (LAR), CRP-to-albumin ratio (CAR), and procalcitonin (PCT)-to-albumin ratio (PAR) in decreased sepsis mortality according to APACHE II Scale.

  1 month

Study Arms (1)

Group 1

Patients newly admitted to ICU with sepsis or septic shock with manifestations suggestive of sepsis according to the guidelines of the 3rd International consensus definitions for sepsis and septic shock.

Diagnostic Test: serum albumin; Diagnostic Test: C-Reactive Protein; Diagnostic Test: Serum procalcitonin; Drug: Blood Lactate

Interventions

serum albumin DIAGNOSTIC_TEST

Serum albumin ratios were calculated as the ratio between the estimated blood lactate, and serum levels of CRP and PCT divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR), CRP-to-albumin ratio (CAR) and procalcitonin (PCT)-to-albumin ratio (PAR).

Group 1

C-Reactive Protein DIAGNOSTIC_TEST

The serum levels of C-reactive protein (CRP) are divided by the estimated serum albumin level to get the CRP-to-albumin ratio (CAR).

Group 1

Serum procalcitonin DIAGNOSTIC_TEST

The serum levels of procalcitonin (PCT) are divided by the estimated serum albumin level to get the PCT-to-albumin ratio (PAR).

Group 1

Blood Lactate DRUG

The serum levels of blood lactate are divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR).

Group 1

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of all patients admitted to the Surgical Intensive Care Unit with manifestations suggestive of sepsis according to the guidelines of the 3rd International Consensus definitions for sepsis and septic shock.

You may qualify if:

• Patients newly admitted to ICU with sepsis or septic shock;

You may not qualify if:

• Patients with acute kidney injury;
• Patients with hemorrhagic shock;
• Patients with immunosuppressive or autoimmune disorders;
• Patients suspected to die in ICU.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: September 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

EG (1)