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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critically Ill; Abdominal Sepsis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Mohammed K. Abdellah, Bachelor; Phone Number: +201220930015; Email: dr.mohammed.khaled7@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut university hospitals
    • Contact: Safaa Abdelsattar, Prof; Phone Number: +201064170058; Email: Safaakhaled2003@gmail.com
    • Contact: Dina Hammad, Prof; Phone Number: +201063040703; Email: Dinaalihamad@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

A total sample size of 120 individuals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Safaa Abdelsattar, Prof, Assiut University; Study Director: Dina Hammad, Prof, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Blood indices of systemic inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Disease Attributes; Sepsis; Toxemia; Inflammation; Intraabdominal Infections; Critical Illness
• Other Study ID Numbers: Abdominal sepsis in ICU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No