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

NCT ID: NCT06095830

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Abdominal Sepsis Critically Ill

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients that recovered from sepsis without complications

Complete blood count

Intervention Type DIAGNOSTIC_TEST

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

Complete blood count

Intervention Type DIAGNOSTIC_TEST

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

Complete blood count

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Safaa AA Khaled

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safaa Abdelsattar, Prof

Role: STUDY_DIRECTOR

Assiut University

Dina Hammad, Prof

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohammed K. Abdellah, Bachelor

Role: CONTACT

+201220930015

Facility Contacts

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Safaa Abdelsattar, Prof

Role: primary

+201064170058

Dina Hammad, Prof

Role: backup

+201063040703

Other Identifiers

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Abdominal sepsis in ICU

Identifier Type: -

Identifier Source: org_study_id

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