- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825118
N\L Ratio Versus L\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock
Neutrophil-lymphocyte Ratio Versus Lactate-albumin Ratio as a Predictor of Morbidity and Mortality in Patients With Sepsis and Septic Shock
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Walaa A Elbialy, resident
- Phone Number: +201095519412
- Email: walaa161071_pg@med.tanta.edu.eg
Study Locations
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Tanta, Egypt
- Recruiting
- Tanta U
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Contact:
- Walaa A Elbialy, resident
- Phone Number: +201095519412
- Email: walaa161071_pg@med.tanta.edu.egy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- 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.
Exclusion criteria
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction of 28 day mortality.
Time Frame: 28 days
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Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge).
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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SOFA score for assessment of organ dysfunction in 0 hours, 6 hours, 24 hours of admission to icu.
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0 hours, 6 hours, 24 hours of admission to icu
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sabry M Ameen, professor, Tanta University
- Study Director: Ahmed A abdelhafez, assist. pro, Tanta University
- Principal Investigator: Alaa M Abohagar, lecturer, Tanta University
Publications and helpful links
General 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.
- Gaieski 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.
- Cao 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N\L and L\A in sepsis
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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