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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06095830

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Sepsis Critically Ill	Diagnostic Test: Complete blood count

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Value of Blood Indices of Systemic Inflammation in Intensive Care Unit Patients With Abdominal Sepsis

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Patients that recovered from sepsis without complications	Diagnostic Test: Complete 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
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 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
Group 3 Control group of healthy individuals	Diagnostic Test: Complete 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

Arm

Intervention/Treatment

Group 1

Patients that recovered from sepsis without complications

Diagnostic Test: Complete 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

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

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

Group 3

Control group of healthy individuals

Diagnostic Test: Complete 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

Outcome Measures

Primary Outcome Measures

Estimation of the prognostic value of blood indices of systemic inflammation [Baseline]
Correlate between the blood indices of systemic inflammation and the prognosis of the patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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