SepsisSOFA-PROVSNLNCT06847477
SOFA Score with Serum Procalcitonin Versus SOFA Score with Neutrophil/lymphocyte Ratio in Predicting Sepsis and Clinical Outcomes in I.C.U.
An observational study of Sepsis and Critical Illness, run by Ain Shams University.
Trial summary
Sepsis remains a critical life-threatening and a healthcare challenge worldwide. Sepsis is implicated in a mortality rate that ranges between 25 - 30% in severe cases and 40-70% in septic shock, also, Post sepsis, lower quality of life was observed among survivors, therefore early prediction and a rapid therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sepsis, Critical Illness
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients presented to Surgical and Trauma intensive care unit
Who may be able to join
- critically ill patients admitted to ICU for surgical or trauma causes.
Who cannot join
- Lack of consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SOFA Score with Serum Procalcitonin Versus SOFA Score with Neutrophil/lymphocyte Ratio in Predicting Sepsis and Clinical Outcomes in Intensive Care Unit.
Sepsis remains a critical life-threatening and a healthcare challenge worldwide. Sepsis is implicated in a mortality rate that ranges between 25 - 30% in severe cases and 40-70% in septic shock, also, Post sepsis, lower quality of life was observed among survivors, therefore early prediction and a rapid therapeutic decision, are essential to improve patient outcomes.
Different indicators are proposed as predictors but with different sensitivity, specificity, and availability. This study aims to evaluate the efficacy of PCT and SOFA scores versus SOFA and NLR in predicting morbidity and mortality outcomes in sepsis.
Read the detailed description
Sepsis provokes a dysregulated host response to infection that leads to acute organ dysfunction. The subsequent Septic shock, which includes an underlying circulatory and cellular imbalance increases the mortality. Septic shock manifests as persistent hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) in the absence of hypovolemia.
Sequential Organ Failure Assessment score (SOFA) has become extensively used and one of the gold standard tests in assessing the patient's status during intensive care unit (ICU) stay and predicting the clinical outcomes of the patients, however, poor sensitivity of SOFA score is a major limitation that excludes its use as a screening tool for early sepsis, the stage in which treatment is most effective. Blood culture is a well-established diagnostic test for sepsis, however, has limitations e.g. prolonged incubation time and probability of false-negative results.
Procalcitonin (PCL) has been studied as a sepsis biomarker, to help with sepsis diagnosis and to guide the initiation and cessation of antibiotics. Procalcitonin strongly correlates with the extent and severity of bacterial infections, better indicator of illness severity than CRP, and also, provides a quick result compared to blood cultures. Procalcitonin use may be hindered by availability and the cost in a limited resources environment, However, The neutrophil-to-lymphocyte ratio (NLR) is a readily available marker. The neutrophil-to-lymphocyte ratio (NLR) is an indicator of systemic inflammation based on complete blood count values. In general, blood neutrophil count increases with the progress of the inflammatory disease, NLR is more reliable when predicting patient survival than either neutrophil count or lymphocyte count alone.
Endogenous cortisol and catecholamines increase the neutrophil count while simultaneously decreasing the lymphocyte count so it may be major drivers of the NLR. Also, cytokines and other hormones are likely to be involved. So NLR is not solely an indication of infection or inflammation. Any cause of physiologic stress may increase the NLR (e.g. hypovolemic shock). NLR increases rapidly following acute physiologic stress (<6 hours). This prompt response time may make NLR a better reflection of acute stress. Interpretation of NLR level is as follows: A normal NLR is roughly 1-3, An NLR of 6-9 suggests mild stress and Critically ill patients will often have an NLR of ~9 or higher (occasionally reaching values close to 100).
This research will test the predictability of combined SOFA score and procalcitonin versus combined SOFA score and NLR for clinical outcomes such as length of ICU stay and mortality.
- Conditions
- Sepsis, Critical Illness
- Keywords
- SOFA score, procalcitonin, neutrophils to lymphocytes ratio
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients presented to Surgical and Trauma intensive care | Critically ill patients who are presented to the Surgical and Trauma intensive care unit will be assessed on admission to ICU by SOFA score, procalcitonin, and neutrophils/lymphocytes ratio. then the patients will be followed to measure the length of stay and mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU stay
It includes the total number of days spent in the ICU, calculated from the time of admission to the time of discharge from the ICU or death, whichever comes first.
The unit of measurement is days.
Measured: from the time of admission to the time of discharge from the ICU or death up to 40 days from ICU admission
Secondary outcomes (2)
28 days mortality
the occurrence of the event of mortality. It will be followed from the day of admission at the ICU and up to 28 days
Measured: From the day of admission at the ICU and up to 28 days.
Antibiotics used
Duration and number of antibiotic usage: measured by the time of the first dose of antibiotics till the time of the last dose administration in the ICU.
Measured: From ICU admission to discharge from ICU or death which comes first up to 40 days from admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847477
- Sponsor's protocol ID
- FMASU R24/2025
- Acronym
- SOFA-PROVSNL
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be shared under reasonable request
Publications
Kumar R, Kattimani B, Ojha PR, Khasage UJ. Quick Sequential Organ Failure Assessment Score, Lactate, and Neutrophil-Lymphocyte Ratio Help in Diagnosis and Mortality Prediction during Golden Hour of Sepsis in Emergency Department. J Emerg Trauma Shock. 2023 Oct-Dec;16(4):161-166. doi: 10.4103/jets.jets_37_23. Epub 2023 Oct 24.
PubMed 38292274Bajic D, Matijasevic J, Andrijevic L, Zaric B, Lalic-Popovic M, Andrijevic I, Todorovic N, Mihajlovic A, Tapavicki B, Ostojic J. Prognostic Role of Monocyte Distribution Width, CRP, Procalcitonin and Lactate as Sepsis Biomarkers in Critically Ill COVID-19 Patients. J Clin Med. 2023 Feb 2;12(3):1197. doi: 10.3390/jcm12031197.
PubMed 36769843
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOFA Score with Serum Procalcitonin Versus SOFA Score with Neutrophil/lymphocyte Ratio in Predicting Sepsis and Clinical Outcomes in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT06847477
- Acronym / sponsor ID
- SOFA-PROVSNL / FMASU R24/2025
- Conditions
- Sepsis, Critical Illness
- Keywords
- SOFA score, procalcitonin, neutrophils to lymphocytes ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Feb 2025 (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 critical life-threatening and a healthcare challenge worldwide. Sepsis is implicated in a mortality rate that ranges between 25 - 30% in severe cases and 40-70% in septic shock, also, Post sepsis, lower quality of life was observed among survivors, therefore early prediction and a rapid therapeutic decision, are essential to improve patient outcomes.
Different indicators are proposed as predictors but with different sensitivity, specificity, and availability. This study aims to evaluate the efficacy of PCT and SOFA scores versus SOFA and NLR in predicting morbidity and mortality outcomes in sepsis.
Detailed description
Sepsis provokes a dysregulated host response to infection that leads to acute organ dysfunction. The subsequent Septic shock, which includes an underlying circulatory and cellular imbalance increases the mortality. Septic shock manifests as persistent hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) in the absence of hypovolemia.
Sequential Organ Failure Assessment score (SOFA) has become extensively used and one of the gold standard tests in assessing the patient's status during intensive care unit (ICU) stay and predicting the clinical outcomes of the patients, however, poor sensitivity of SOFA score is a major limitation that excludes its use as a screening tool for early sepsis, the stage in which treatment is most effective. Blood culture is a well-established diagnostic test for sepsis, however, has limitations e.g. prolonged incubation time and probability of false-negative results.
Procalcitonin (PCL) has been studied as a sepsis biomarker, to help with sepsis diagnosis and to guide the initiation and cessation of antibiotics. Procalcitonin strongly correlates with the extent and severity of bacterial infections, better indicator of illness severity than CRP, and also, provides a quick result compared to blood cultures. Procalcitonin use may be hindered by availability and the cost in a limited resources environment, However, The neutrophil-to-lymphocyte ratio (NLR) is a readily available marker. The neutrophil-to-lymphocyte ratio (NLR) is an indicator of systemic inflammation based on complete blood count values. In general, blood neutrophil count increases with the progress of the inflammatory disease, NLR is more reliable when predicting patient survival than either neutrophil count or lymphocyte count alone.
Endogenous cortisol and catecholamines increase the neutrophil count while simultaneously decreasing the lymphocyte count so it may be major drivers of the NLR. Also, cytokines and other hormones are likely to be involved. So NLR is not solely an indication of infection or inflammation. Any cause of physiologic stress may increase the NLR (e.g. hypovolemic shock). NLR increases rapidly following acute physiologic stress (<6 hours). This prompt response time may make NLR a better reflection of acute stress. Interpretation of NLR level is as follows: A normal NLR is roughly 1-3, An NLR of 6-9 suggests mild stress and Critically ill patients will often have an NLR of ~9 or higher (occasionally reaching values close to 100).
This research will test the predictability of combined SOFA score and procalcitonin versus combined SOFA score and NLR for clinical outcomes such as length of ICU stay and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients presented to Surgical and Trauma intensive care | – | –Critically ill patients who are presented to the Surgical and Trauma intensive care unit will be assessed on admission to ICU by SOFA score, procalcitonin, and neutrophils/lymphocytes ratio. then the patients will be followed to measure the length of stay and mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients presented to Surgical and Trauma intensive care unit
Key inclusion criteria (1 listed)
- critically ill patients admitted to ICU for surgical or trauma causes.
Key exclusion criteria (1 listed)
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of ICU stay
Time frame: from the time of admission to the time of discharge from the ICU or death up to 40 days from ICU admission
It includes the total number of days spent in the ICU, calculated from the time of admission to the time of discharge from the ICU or death, whichever comes first. The unit of measurement is days.
2 secondary outcomes
28 days mortality
Time frame: From the day of admission at the ICU and up to 28 days.
Antibiotics used
Time frame: From ICU admission to discharge from ICU or death which comes first up to 40 days from admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 38292274Kumar R, Kattimani B, Ojha PR, Khasage UJ. Quick Sequential Organ Failure Assessment Score, Lactate, and Neutrophil-Lymphocyte Ratio Help in Diagnosis and Mortality Prediction during Golden Hour of Sepsis in Emergency Department. J Emerg Trauma Shock. 2023 Oct-Dec;16(4):161-166. doi: 10.4103/jets.jets_37_23. Epub 2023 Oct 24.
- Background: PubMed 36769843Bajic D, Matijasevic J, Andrijevic L, Zaric B, Lalic-Popovic M, Andrijevic I, Todorovic N, Mihajlovic A, Tapavicki B, Ostojic J. Prognostic Role of Monocyte Distribution Width, CRP, Procalcitonin and Lactate as Sepsis Biomarkers in Critically Ill COVID-19 Patients. J Clin Med. 2023 Feb 2;12(3):1197. doi: 10.3390/jcm12031197.
- Individual participant dataSharing planned: Undecided. May be shared under reasonable request
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by Ain Shams University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wessam zaher selima, MD (0021001958858, w.z.selima@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU stay (time frame: from the time of admission to the time of discharge from the ICU or death up to 40 days from ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847477, which also lists 2 linked publications.
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 26 Feb 2025.