NCT06095830

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 18, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

Blood indices of systemic inflammation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1

Patients that recovered from sepsis without complications

Diagnostic Test: Complete blood count

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

Group 3

Control group of healthy individuals

Diagnostic Test: Complete blood count

Interventions

Complete blood countDIAGNOSTIC_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 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total sample size of 120 individuals

You may qualify if:

  • Patients above the age of 18 years old.
  • Patients fulfilling the Systemic Inflammatory Response Syndrome (SIRS) criteria.
  • Patients with an established diagnosis of abdominal sepsis, clinically and by investigations.

You may not qualify if:

  • Patients below the age of 18 years.
  • Patients with haematological disorders.
  • Patients with concomitant severe morbidity affecting the prognosis other than sepsis e.g. hypovolemic shock, brainstem infarction, pulmonary embolism, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Intraabdominal InfectionsCritical Illness

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Safaa Abdelsattar, Prof

    Assiut University

    STUDY DIRECTOR
  • Dina Hammad, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohammed K. Abdellah, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 23, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations