SepsisNCT05914480
Sepsis in ICU:Causes and Outcomes in Diabetics and Non Diabetics
An observational study of Sepsis, run by Assiut University.
Trial summary
Identify prevalence of sepsis in ICU of Assiut university hospital 2.Clarify different causes of sepsis in patients admitted to ICU . 3.Compare causes and outcomes of sepsis between diabetics versus non diabetics . 4.Screening for the co1.mmonest organism causing sepsis in critically ill patients . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- PCR for legionella ,blood ,urine cultures and from catheters or source of infection
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Aug 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to ICU diagnosed as sepsis or septic shock even on admission or later on then subdivided into 2 groups 1_Hyperglycemic (diabetic and non diabetic) .2_Normoglycemic(diabetic and non diabetic)
Who may be able to join
- according to sofa criteria Suspected /documented infection+sofa score >_2 or +ve Q sofa defined as 2or more 1_ hypotesion SBP<90.2_altered mental status GCS<13 3_ Exclusion Criteria:tachypnea>22 or septic shock criteria
- previous history of pulmonary problem Previous history of cardiac disease Previous history of autoimmune disease
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sepsis in ICU: Causes and Outcomes in Diabetics and Non Diabetics in Assiut University Hospital
Identify prevalence of sepsis in ICU of Assiut university hospital 2.Clarify different causes of sepsis in patients admitted to ICU . 3.Compare causes and outcomes of sepsis between diabetics versus non diabetics .
4.Screening for the co1.mmonest organism causing sepsis in critically ill patients .
Read the detailed description
Sepsis, is defined as an infection with organ dysfunction, There is wide variation in sepsis rates, causative microorganisms, and outcome in ICU patients around the world.
Many conservative estimates considered sepsis as a leading cause of mortality and critical illness worldwide .
sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock .
Factors such as advancing age, immunosuppression and multidrug-resistant infection play a role in increasing incidence of sepsis during recent decades .
Patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications.
Patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients.
The prevalence of diabetes mellitus in ICU patients is as high as 30%, And such patients are at increased risk of experiencing in-hospital Complications, compared to patients without diabetes.
Infective complications may be reduced with lower blood glucose concentrations Moreover, in critically ill patients without diabetes, Hyperglycemia is associated with increased mortality, risk of infection, Kidney injury and cardiovascular complications.
Moreover, diabetes is a major risk factor for both Acute Kidney Injury and sepsis.
Sepsis also is a major cause of Acute Kidney Injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteraemia or shock .
Sepsis-related AKI is associated with high mortality rates of up to 70%.
- Conditions
- Sepsis
- Being tested
- PCR for legionella ,blood ,urine cultures and from catheters or source of infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR for legionella ,blood ,urine cultures and from catheters or source of infectionOther
Investigations to detect cause of sepsis as blood cultures ,urine cultures and from catheters .also PCR for legionella will be done
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the most common organism causing sepsis in ICU
Applying culture and sensitivity test for patients developed sepsis on admission and follow up will direct us for appropriate treatment for all patients
Measured: 20 days
Secondary outcomes (1)
Incidence of sepsis in diabetics versus non diabetics in ICU.
Assess the effect of hyperglycemia on spsis outcomes.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed fathi mansour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914480
- Sponsor's protocol ID
- Sepsis pts investigate causes
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 26 Jun 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis in ICU: Causes and Outcomes in Diabetics and Non Diabetics in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05914480
- Acronym / sponsor ID
- Sepsis pts investigate causes
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 22 Jun 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.
Identify prevalence of sepsis in ICU of Assiut university hospital 2.Clarify different causes of sepsis in patients admitted to ICU . 3.Compare causes and outcomes of sepsis between diabetics versus non diabetics .
4.Screening for the co1.mmonest organism causing sepsis in critically ill patients .
Detailed description
Sepsis, is defined as an infection with organ dysfunction, There is wide variation in sepsis rates, causative microorganisms, and outcome in ICU patients around the world.
Many conservative estimates considered sepsis as a leading cause of mortality and critical illness worldwide .
sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock .
Factors such as advancing age, immunosuppression and multidrug-resistant infection play a role in increasing incidence of sepsis during recent decades .
Patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications.
Patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients.
The prevalence of diabetes mellitus in ICU patients is as high as 30%, And such patients are at increased risk of experiencing in-hospital Complications, compared to patients without diabetes.
Infective complications may be reduced with lower blood glucose concentrations Moreover, in critically ill patients without diabetes, Hyperglycemia is associated with increased mortality, risk of infection, Kidney injury and cardiovascular complications.
Moreover, diabetes is a major risk factor for both Acute Kidney Injury and sepsis.
Sepsis also is a major cause of Acute Kidney Injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteraemia or shock .
Sepsis-related AKI is associated with high mortality rates of up to 70%.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to ICU diagnosed as sepsis or septic shock even on admission or later on then subdivided into 2 groups 1_Hyperglycemic (diabetic and non diabetic) .2_Normoglycemic(diabetic and non diabetic)
Key inclusion criteria (2 listed)
- according to sofa criteria Suspected /documented infection+sofa score >_2 or +ve Q sofa defined as 2or more 1_ hypotesion SBP<90.2_altered mental status GCS<13 3_ Exclusion Criteria:tachypnea>22 or septic shock criteria
- previous history of pulmonary problem Previous history of cardiac disease Previous history of autoimmune disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PCR for legionella ,blood ,urine cultures and from catheters or source of infectionInvestigations to detect cause of sepsis as blood cultures ,urine cultures and from catheters .also PCR for legionella will be done | Other | – |
Primary outcome
Detect the most common organism causing sepsis in ICU
Time frame: 20 days
Applying culture and sensitivity test for patients developed sepsis on admission and follow up will direct us for appropriate treatment for all patients
1 secondary outcome
Incidence of sepsis in diabetics versus non diabetics in ICU.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Assiut University.
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 2 inclusion and 0 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mai Ahmed fathi, Specialist (01009490399, doc.maiahmad89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the most common organism causing sepsis in ICU (time frame: 20 days). 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 26 Jun 2023.