N\L Ratio Versus L\A Ratio as a Predictor of Morbidity and Mortality in Sepsis and Septic Shock

NCT05825118 | Unknown

• 1 other identifier: N\L and L\A in sepsis
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Prediction of 28 day mortality.

  Prediction of 28 day mortality (patients will be followed by telephone for 28 day after discharge).

  28 days

Secondary Outcomes (1)

• Extent of organ dysfunction in patients with sepsis and septic shock assessed by SOFA score

  0 hours, 6 hours, 24 hours of admission to icu

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta U

Tanta, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 33451890 BACKGROUND

• 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.

  PMID: 23442987 BACKGROUND

• 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.

  PMID: 31611560 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabry M Ameen, professor

  Tanta University

  STUDY CHAIR

• Ahmed A abdelhafez, assist. pro

  Tanta University

  STUDY DIRECTOR

• Alaa M Abohagar, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa A Elbialy, resident

CONTACT

+201095519412; walaa161071_pg@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-03

Locations

EG (1)