Abdominal SepsisNCT06095830
Blood Indices of Systemic Inflammation in Critically Ill Patients With Abdominal Sepsis
An observational study of Abdominal Sepsis and Critically Ill, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Sepsis, Critically Ill
- What is being tested?
- Complete blood count
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: A total sample size of 120 individuals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University Hospitals
Asyut, 71515
Safaa Abdelsattar, Prof, +201064170058, Safaakhaled2003@gmail.com
Dina Hammad, Prof, +201063040703, Dinaalihamad@aun.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Sepsis, Critically Ill
- Being tested
- Complete blood count
- Keywords
- Blood indices of systemic inflammation
- Medical subject headings
- Intraabdominal Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients that recovered from sepsis without complications Receives: 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 Receives: Diagnostic Test: Complete blood count | |
| Group 3 | Control group of healthy individuals Receives: Diagnostic Test: Complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa AA Khaled, Assiut University
- Investigators
- Safaa Abdelsattar, Prof, Study director, Assiut UniversityDina Hammad, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095830
- Sponsor's protocol ID
- Abdominal sepsis in ICU
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Blood Indices of Systemic Inflammation in Intensive Care Unit Patients With Abdominal Sepsis
- ClinicalTrials.gov ID
- NCT06095830
- Acronym / sponsor ID
- Abdominal sepsis in ICU
- Conditions
- Abdominal Sepsis, Critically Ill
- Keywords
- Blood indices of systemic inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Complete blood countPatients that recovered from sepsis without complications |
| Group 2 | – | Diagnostic Test: Complete blood countPatients that didn't recover from sepsis. Further subdivided into: Group 2-A: developed complications Group 2-B: non-surviving |
| Group 3 | – | Diagnostic Test: Complete blood countControl group of healthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total sample size of 120 individuals
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countComplete 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 | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Estimation of the prognostic value of blood indices of systemic inflammation
Time frame: Baseline
Correlate between the blood indices of systemic inflammation and the prognosis of the patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa Abdelsattar, Prof study director
Assiut University
Dina Hammad, Prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Sepsis and Critically Ill, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed K. Abdellah, Bachelor (+201220930015, dr.mohammed.khaled7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the prognostic value of blood indices of systemic inflammation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.