Clinical trial NCT06095830: Blood Indices of Systemic Inflammation in Critically Ill Patients With Abdominal Sepsis
Official title: Value of Blood Indices of Systemic Inflammation in Intensive Care Unit Patients With Abdominal Sepsis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Sepsis
Critically Ill
Keywords: Blood indices of systemic inflammation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total sample size of 120 individuals

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimation of the prognostic value of blood indices of systemic inflammation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Safaa Abdelsattar, Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Dina Hammad, Prof
role: STUDY_DIRECTOR
References: