- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640504
Serum Albumin Ratios Can Improve Sepsis Mortality Prediction
November 22, 2025 updated by: Azza Mahrous Shaffik, Benha University
Serum Albumin Ratios Correct the Ability of Traditional Biomarkers to Predict Mortality of Sepsis Patients Admitted to Surgical ICU
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El Qalyoubia
-
Banhā, El Qalyoubia, Egypt, 13511
- Benha University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- Patients newly admitted to ICU with sepsis or septic shock;
- Patients were free of exclusion criteria.
Exclusion Criteria:
- Patients with acute kidney injury;
- Patients with hemorrhagic shock;
- Patients with immunosuppressive or autoimmune disorders;
- Patients suspected to die in ICU.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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).
The serum levels of C-reactive protein (CRP) are divided by the estimated serum albumin level to get the CRP-to-albumin ratio (CAR).
The serum levels of procalcitonin (PCT) are divided by the estimated serum albumin level to get the PCT-to-albumin ratio (PAR).
The serum levels of blood lactate are divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 1 month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2024
Primary Completion (Actual)
November 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
October 11, 2024
First Submitted That Met QC Criteria
October 11, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
November 28, 2025
Last Update Submitted That Met QC Criteria
November 22, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rc 4-9-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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