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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06095830
• Other study ID #: Abdominal sepsis in ICU
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Mohammed K. Abdellah, Bachelor
• Phone: +201220930015
• Email: dr.mohammed.khaled7[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Sepsis
• Critical Illness
• Critically Ill
• Inflammation
• Intraabdominal Infections
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline