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

Not yet recruiting

• Conditions: Abdominal Sepsis; Critically Ill
• Interventions: Diagnostic Test: Complete blood count

• Registration Number: NCT06095830
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Study Start: 2023-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Complete blood count	Patients that didn't recover from sepsis. Further subdivided into: Group 2-A: developed complications Group 2-B: non-surviving
Group 1	Complete blood count	Patients that recovered from sepsis without complications
Group 3	Complete blood count	Control group of healthy individuals

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt