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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06095830
Other study ID # Abdominal sepsis in ICU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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