NCT06847477

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 21, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

SOFA scoreprocalcitoninneutrophils to lymphocytes ratio

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From the day of admission at the ICU and up to 28 days.

  • Antibiotics used

    From ICU admission to discharge from ICU or death which comes first up to 40 days from admission.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients presented to Surgical and Trauma intensive care unit

You may qualify if:

  • critically ill patients admitted to ICU for surgical or trauma causes.

You may not qualify if:

  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 38292274BACKGROUND
  • Bajic 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.

    PMID: 36769843BACKGROUND

MeSH Terms

Conditions

SepsisCritical Illness

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

wessam zaher selima, MD

CONTACT

Basma sherif Fahmy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

March 1, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02