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Not yet recruitingNCT06095830Updated Oct 23, 2023

Blood Indices of Systemic Inflammation in Critically Ill Patients With Abdominal Sepsis

An observational study in Abdominal Sepsis and Critically Ill, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to clarify the role of blood indices of systemic inflammation in ICU-admitted patients with abdominal sepsis to assess their diagnostic significance as well as their prognostic value.

Read the detailed description

Sepsis is a complex, multifactorial syndrome which can evolve into conditions of varying severity. If left untreated, it may lead to the functional impairment of one or more vital organs or systems. Severity of illness and the inherent mortality risk escalate from sepsis, through severe sepsis (defined as sepsis associated with at least one acute organ dysfunction, hypoperfusion, or hypotension) and septic shock up multi-organ failure. Previous studies have demonstrated that mortality rates increase dramatically in the event of severe sepsis and septic shock.

Abdominal infection is a common indication for admission to the intensive care unit (ICU) and the abdomen is the second most common site of invasive infection among critically ill patients in epidemiological and therapeutic studies. Abdominal infections are more often associated with septic shock and acute kidney injury than are infections in other sites. The spectrum of disease and severity is broad and management of these infections is challenging.

The inflammatory response in patients with sepsis depends on the causative pathogen and the host (genetic characteristics and coexisting illnesses), with differential responses at local, regional, and systemic levels.

On the systemic level, several indices have been used as a mirror to outcome in patients with various pathologies, of which are the Blood Indices of Systemic Inflammation.

As these blood indices are easy and available investigation that may be promising predictors in sepsis, we aim in this study to evaluate their role in abdominal sepsis.

02

Conditions studied

  • Abdominal Sepsis
  • Critically Ill

Keywords

  • Blood indices of systemic inflammation
03

In context

Sepsis

1,903 studies on the registry are indexed under Sepsis; 466 are open to participants now.

This study's planned enrollment of 120 is below the median of 160 across 932 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

A total sample size of 120 individuals

Inclusion criteria

  1. Patients above the age of 18 years old.
  2. Patients fulfilling the Systemic Inflammatory Response Syndrome (SIRS) criteria.
  3. Patients with an established diagnosis of abdominal sepsis, clinically and by investigations.

Exclusion criteria

Exclusion Criteria:

  1. Patients below the age of 18 years.
  2. Patients with haematological disorders.
  3. Patients with concomitant severe morbidity affecting the prognosis other than sepsis e.g. hypovolemic shock, brainstem infarction, pulmonary embolism, etc.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Patients that recovered from sepsis without complications

    Diagnostic Test: Complete blood count

  • Group 2

    Patients that didn't recover from sepsis. Further subdivided into: Group 2-A: developed complications Group 2-B: non-surviving

    Diagnostic Test: Complete blood count

  • Group 3

    Control group of healthy individuals

    Diagnostic Test: Complete blood count

Interventions

  • Diagnostic testComplete blood count

    Complete blood count done on admission and on discharge for patients, from which the blood indices of systemic inflammation will be calculated and correlated with outcome

06

What researchers measure

Primary outcomes

  1. Estimation of the prognostic value of blood indices of systemic inflammation

    Correlate between the blood indices of systemic inflammation and the prognosis of the patients.

    Time frame: Baseline

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06095830
Lead sponsor
Assiut University
Responsible party
Safaa AA Khaled (Prof., Assiut University) — Principal investigator
First posted
Oct 23, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Oct 23, 2023

Study contacts

Mohammed K. Abdellah, Bachelor
Contact
dr.mohammed.khaled7@gmail.com
+201220930015
Safaa Abdelsattar, Prof
study director · Assiut University
Dina Hammad, Prof
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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