SepsisNCT06640504
Serum Albumin Ratios Can Improve Sepsis Mortality Prediction
An observational study of Sepsis, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- serum albumin, C-Reactive Protein and Serum procalcitonin
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients newly admitted to ICU with sepsis or septic shock;
- Patients were free of exclusion criteria.
Who cannot join
- Patients with acute kidney injury;
- Patients with hemorrhagic shock;
- Patients with immunosuppressive or autoimmune disorders;
- Patients suspected to die in ICU.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis
- Being tested
- serum albumin, C-Reactive Protein, Serum procalcitonin, Blood Lactate
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum albuminDiagnostic 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).
C-Reactive ProteinDiagnostic 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).
Serum procalcitoninDiagnostic test
The serum levels of procalcitonin (PCT) are divided by the estimated serum albumin level to get the PCT-to-albumin ratio (PAR).
Blood LactateDrug
The serum levels of blood lactate are divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: serum albumin; Diagnostic Test: C-Reactive Protein; Diagnostic Test: Serum procalcitonin; Drug: Blood Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Sep 2024
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mahrous Shaffik, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640504
- Sponsor's protocol ID
- Rc 4-9-2024
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Albumin Ratios Correct the Ability of Traditional Biomarkers to Predict Mortality of Sepsis Patients Admitted to Surgical ICU
- ClinicalTrials.gov ID
- NCT06640504
- Acronym / sponsor ID
- Rc 4-9-2024
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: serum albumin, Diagnostic Test: C-Reactive Protein, Diagnostic Test: Serum procalcitonin, Drug: Blood LactatePatients 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients newly admitted to ICU with sepsis or septic shock;
- Patients were free of exclusion criteria.
Key exclusion criteria (4 listed)
- Patients with acute kidney injury;
- Patients with hemorrhagic shock;
- Patients with immunosuppressive or autoimmune disorders;
- Patients suspected to die in ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum albuminSerum 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). | Diagnostic test | Group 1 |
| C-Reactive ProteinThe serum levels of C-reactive protein (CRP) are divided by the estimated serum albumin level to get the CRP-to-albumin ratio (CAR). | Diagnostic test | Group 1 |
| Serum procalcitoninThe serum levels of procalcitonin (PCT) are divided by the estimated serum albumin level to get the PCT-to-albumin ratio (PAR). | Diagnostic test | Group 1 |
| Blood LactateThe serum levels of blood lactate are divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR). | Drug | Group 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.