NCT07200817

Brief Summary

This study aims to compare Neutrophil to Lymphocyte and Platelet Ratio, Procalcitonin, and Total Leucocyte Count as indicators of prognostic outcome in septic patients in the intensive care unit.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

September 23, 2025

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Levels of Neutrophils to Lymphocytes and Platelets ratio

    The ratio of neutrophils to Lymphocytes and Platelets in relation to 28-day mortality among septic patients will be recorded.

    28 days post-procedure

Secondary Outcomes (2)

  • Procalcitonin (PCT)

    28 days post-procedure

  • Total Leukocytic Count (TLC)

    28 days post-procedure

Study Arms (1)

Study group

Septic patients (under the third international consensus definitions of sepsis and septic shock)

Diagnostic Test: Neutrophils to Lymphocytes and Platelets ratio (N/LP)

Interventions

The Neutrophils to Lymphocytes and Platelets ratio (N/LP) will be measured

Study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospective observational study will be conducted at Ain Shams University Hospital, Cairo, Egypt.

You may qualify if:

  • Age from 18 to 70 years old.
  • Both sexes.
  • Septic patients (under the third international consensus definitions of sepsis and septic shock).

You may not qualify if:

  • Pregnancy
  • Malignancy
  • On immunosuppressive therapy
  • Hematological Disorders
  • Major Trauma
  • Major Burns
  • Child-Pugh Class C Liver Cirrhosis
  • On Hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

Michael G Farag, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Egypt.

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

September 20, 2024

Primary Completion

March 19, 2026

Study Completion

March 19, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations