SepsisNCT05825118
N\L Ratio Versus L\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock
An observational study of Sepsis, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to compare between neutrophil lymphocyte ratio and lactate albumin ratio as a predictor of morbidity and mortality in sepsis and septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to Oct 2023
- 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 18 to 60 years
- All sexes
- Adult
Study population: All patient of both sex with age between 18-60 years old admitted to SICU suffering from sepsis and septic shock will be enrolled in the study after fulfillment of the following inclusion and exclusion criteria
Who may be able to join
- Age from 18 to 60 years old.
- Patients with suspected infection who fulfilled at least two of three quick sepsis - related organ failure assessment (QSOFA) criteria
- Patients with Organ dysfunction can be confirmed by acute change in SOFA score variables >2 points consequent to infection.
- Sepsis with persisting hypotension requiring vasopressors to maintain MAP > 65 mm Hg and having a serum lactate level > 2mmol/L despite adequate volume of resuscitation.
Who cannot join
- No informed consent.
- Malignancy and chemotherapy during the previous 90 days.
- History of steroid therapy within 3 months before admission.
- Patients with either established hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burn.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta U
Tanta
Walaa A Elbialy, resident, +201095519412, walaa161071_pg@med.tanta.edu.egy
About this study
Official title: Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio as a Predictor of Morbidity and Mortality in Patients With Sepsis and Septic Shock
The aim of the study is to compare between neutrophil lymphocyte ratio and lactate albumin ratio as a predictor of morbidity and mortality in sepsis and septic shock patients.
Read the detailed description
Sepsis is a systemic inflammatory response syndrome caused by infection can lead to life threatening multi-organ dysfunction.
Septic shock causes circulatory and metabolic abnormalities, leading to increased mortality in hospitalized patients, especially in intensive care unit (ICU) patients.
Sepsis can affect the function and number of immune cells, including neutrophils, lymphocytes and monocytes.
Neutrophils play crucial roles in the innate cellular immune system. Early higher neutrophil counts correlated with increased sepsis severity.
In sepsis, lymphocytes decrease owing to the apoptosis mediated by innate response.
Reversily, number of neutrophils dramatically increase reflecting degree of inflammation.
The neutrophil-to-lymphocyte ratio (NLR) is a novel inflammatory biomarker that can be obtained through blood routine tests, it is cost- effective and widely available, and it is beneficial to the early recognition of poor prognosis in septic patients.
Albumin is a molecule that is the most abundant protein in plasma. For a variety of physiological mechanisms, albumin has a variety of function, including serving as a major buffer, extracellular antioxidant, immune modulator, antidote and transporter in plasma.
Increased capillary leakage of albumin is one of the features of SIRS. This means that lower albumin levels correlate with severe systemic inflammation and organ failure.
Hypoxia and tissue hypo perfusion seen in sepsis play a key role on the development of multi-organ failure in septic patients.
Lactic acidosis is one of the best indicators of the insufficient perfusion or development of anaerobic metabolism during septic shock.
The inability of liver to metabolize lactate as a result of the deterioration of liver perfusion also increases lactate levels.
The measurement of blood lactate levels used to determine tissue hypoxia is rapid, inexpensive and easy.
Because lactate and albumin levels progress differently as the development of sepsis proceeds, a ratio between the two rather than analyzing lactate and albumin alone may be a new and perhaps better indicator for the patient's prognosis.
- Conditions
- Sepsis
- Being tested
- Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.Diagnostic test
Blood will be drawn from peripheral vein, arterial or a central catheter for evaluation of whole blood count, serum lactate and serum albumin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of 28 day mortality.
Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge).
Measured: 28 days
Secondary outcomes (1)
Extent of organ dysfunction in patients with sepsis and septic shock assessed by SOFA score
SOFA score for assessment of organ dysfunction in 0 hours, 6 hours, 24 hours of admission to icu.
Measured: 0 hours, 6 hours, 24 hours of admission to icu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Adel Abdelghafar Elbialy, Tanta University
- Investigators
- Sabry M Ameen, professor, Study chair, Tanta UniversityAhmed A abdelhafez, assist. pro, Study director, Tanta UniversityAlaa M Abohagar, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825118
- Sponsor's protocol ID
- N\L and L\A in sepsis
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
Publications
Fortini A, Faraone A, Meini S, Bettucchi M, Longo B, Valoriani B, Forni S; Italian Federation of Hospital Internists (FADOI) - Sepsis Collaboration Group of the Tuscany Region. Validity of "Sepsis-3" criteria in identifying patients with community-onset sepsis in Internal Medicine wards; a prospective, multicenter study. Eur J Intern Med. 2021 Mar;85:92-97. doi: 10.1016/j.ejim.2020.12.025. Epub 2021 Jan 12.
PubMed 33451890Gaieski DF, Edwards JM, Kallan MJ, Carr BG. Benchmarking the incidence and mortality of severe sepsis in the United States. Crit Care Med. 2013 May;41(5):1167-74. doi: 10.1097/CCM.0b013e31827c09f8.
PubMed 23442987Cao C, Yu M, Chai Y. Pathological alteration and therapeutic implications of sepsis-induced immune cell apoptosis. Cell Death Dis. 2019 Oct 14;10(10):782. doi: 10.1038/s41419-019-2015-1.
PubMed 31611560
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio as a Predictor of Morbidity and Mortality in Patients With Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT05825118
- Acronym / sponsor ID
- N\L and L\A in sepsis
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Apr 2023 (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.
The aim of the study is to compare between neutrophil lymphocyte ratio and lactate albumin ratio as a predictor of morbidity and mortality in sepsis and septic shock patients.
Detailed description
Sepsis is a systemic inflammatory response syndrome caused by infection can lead to life threatening multi-organ dysfunction.
Septic shock causes circulatory and metabolic abnormalities, leading to increased mortality in hospitalized patients, especially in intensive care unit (ICU) patients.
Sepsis can affect the function and number of immune cells, including neutrophils, lymphocytes and monocytes.
Neutrophils play crucial roles in the innate cellular immune system. Early higher neutrophil counts correlated with increased sepsis severity.
In sepsis, lymphocytes decrease owing to the apoptosis mediated by innate response.
Reversily, number of neutrophils dramatically increase reflecting degree of inflammation.
The neutrophil-to-lymphocyte ratio (NLR) is a novel inflammatory biomarker that can be obtained through blood routine tests, it is cost- effective and widely available, and it is beneficial to the early recognition of poor prognosis in septic patients.
Albumin is a molecule that is the most abundant protein in plasma. For a variety of physiological mechanisms, albumin has a variety of function, including serving as a major buffer, extracellular antioxidant, immune modulator, antidote and transporter in plasma.
Increased capillary leakage of albumin is one of the features of SIRS. This means that lower albumin levels correlate with severe systemic inflammation and organ failure.
Hypoxia and tissue hypo perfusion seen in sepsis play a key role on the development of multi-organ failure in septic patients.
Lactic acidosis is one of the best indicators of the insufficient perfusion or development of anaerobic metabolism during septic shock.
The inability of liver to metabolize lactate as a result of the deterioration of liver perfusion also increases lactate levels.
The measurement of blood lactate levels used to determine tissue hypoxia is rapid, inexpensive and easy.
Because lactate and albumin levels progress differently as the development of sepsis proceeds, a ratio between the two rather than analyzing lactate and albumin alone may be a new and perhaps better indicator for the patient's prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All patient of both sex with age between 18-60 years old admitted to SICU suffering from sepsis and septic shock will be enrolled in the study after fulfillment of the following inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Age from 18 to 60 years old.
- Patients with suspected infection who fulfilled at least two of three quick sepsis - related organ failure assessment (QSOFA) criteria
- Patients with Organ dysfunction can be confirmed by acute change in SOFA score variables >2 points consequent to infection.
- Sepsis with persisting hypotension requiring vasopressors to maintain MAP > 65 mm Hg and having a serum lactate level > 2mmol/L despite adequate volume of resuscitation.
Key exclusion criteria (4 listed)
- No informed consent.
- Malignancy and chemotherapy during the previous 90 days.
- History of steroid therapy within 3 months before admission.
- Patients with either established hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burn.
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 |
|---|---|---|
| Neutrophil/Lymphocyte ratio and lactate/ albumin ratio will be measured in all patients.Blood will be drawn from peripheral vein, arterial or a central catheter for evaluation of whole blood count, serum lactate and serum albumin. | Diagnostic test | – |
Primary outcome
Prediction of 28 day mortality.
Time frame: 28 days
Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge).
1 secondary outcome
Extent of organ dysfunction in patients with sepsis and septic shock assessed by SOFA score
Time frame: 0 hours, 6 hours, 24 hours of admission to icu
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 33451890Fortini A, Faraone A, Meini S, Bettucchi M, Longo B, Valoriani B, Forni S; Italian Federation of Hospital Internists (FADOI) - Sepsis Collaboration Group of the Tuscany Region. Validity of "Sepsis-3" criteria in identifying patients with community-onset sepsis in Internal Medicine wards; a prospective, multicenter study. Eur J Intern Med. 2021 Mar;85:92-97. doi: 10.1016/j.ejim.2020.12.025. Epub 2021 Jan 12.
- Background: PubMed 23442987Gaieski DF, Edwards JM, Kallan MJ, Carr BG. Benchmarking the incidence and mortality of severe sepsis in the United States. Crit Care Med. 2013 May;41(5):1167-74. doi: 10.1097/CCM.0b013e31827c09f8.
- Background: PubMed 31611560Cao C, Yu M, Chai Y. Pathological alteration and therapeutic implications of sepsis-induced immune cell apoptosis. Cell Death Dis. 2019 Oct 14;10(10):782. doi: 10.1038/s41419-019-2015-1.
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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.
Sabry M Ameen, professor study chair
Tanta University
Ahmed A abdelhafez, assist. pro study director
Tanta University
Alaa M Abohagar, lecturer principal investigator
Tanta University
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 Tanta 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 4 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa A Elbialy, resident (+201095519412, walaa161071_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of 28 day mortality. (time frame: 28 days). 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 NCT05825118, which also lists 3 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 24 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.