Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

July 10, 2019 updated by: Shaimaa Srour, Assiut University

Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

Clarify different causes of sepsis in patients admitted to ICU . as well asCompare causes and outcomes of sepsis between diabetics versus non diabetics .

3.Screening for the commonest organism causing sepsis in critically ill patients.

Determine better protocol therapy that help in decreasing mortality and morbidity in patients with sepsis in ICU.

Study Overview

Status

Unknown

Conditions

Detailed Description

Sepsis is a physiologic, pathologic, and biochemical abnormalities induced by infection.

sepsis is considered as a leading cause of mortality and critical illness worldwide by many conservative estimates.

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 multi-drug-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.

Infection also remains an important cause of death in diabetics. The prevalence of diabetes mellitus in Intensive Care Unit 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 bacteremia or shock .

Sepsis-related Acute Kidney Injury is associated with high mortality rates of up to 70%.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to ICU and devoloped sepsis or septic shock (even on admission or later-on ) as defined by 3rd consensus guidelines (sepsis 3) ,2016 patients then devided into 3 groups : Group 1: patients with Diabetes Mellitus (type 1or type 2). Group 2: patients with in-hospital hyperglycemia(not known to be diabetic). Group 3 : Normglycemic patients (without past or present history of DM ).

Description

Inclusion Criteria:

patients admitted to ICU for any reason and devoloped sepsis either on admission or later during thier hospital stay. patients having Criteria of sepsis or septic shock as defined by 3rd consensus guidelines (sepsis 3) ,2016

Exclusion Criteria:

Previous history of pulmonary problem . Previous history of cardiac disease. Previous history of Autoimmune disease immunocompromised patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetics
  1. Full history with special attention to:

    Causes of admission to ICU . Duration of DM when present, medication used, controlled or not.

  2. Complete physical examination with special attention to :

    Vital signs ( MAP, pulse, temp, RR). Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..).

  3. Laboratory investigations includes :

CBC , Liver and kidney functions → baseline and follow up. Arterial Blood Gases (ABG). Lactic acid level. HBA1C. ESR, CRP →baseline and follow up.

Culture :

On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.

ESR ,CRP,CBC, Renal and Liver function will be done on admission and follow up Culture: On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
Other Names:
  • HbA1C
  • Arterial Blood Gases
  • Lactic acid level
  • CBC
  • ESR
  • CRP
  • liver and kidney function tests
non diabetics
  1. Full history with special attention to:

    Causes of admission to ICU . Duration of DM when present medication used, controlled or not.

  2. Complete physical examination with special attention to :

    Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..).

  3. Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline and follow up.

Culture :

On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.

ESR ,CRP,CBC, Renal and Liver function will be done on admission and follow up Culture: On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
Other Names:
  • HbA1C
  • Arterial Blood Gases
  • Lactic acid level
  • CBC
  • ESR
  • CRP
  • liver and kidney function tests
patients devoloped hyperglycemia in ICU only

Full history with special attention to:

Causes of admission to ICU . Duration of DM when present medication used, controlled or not. 2. Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, CVP,..). 3. Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline and follow up.

Culture :

On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.

ESR ,CRP,CBC, Renal and Liver function will be done on admission and follow up Culture: On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
Other Names:
  • HbA1C
  • Arterial Blood Gases
  • Lactic acid level
  • CBC
  • ESR
  • CRP
  • liver and kidney function tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect the most common organism causing sepsis in ICU .
Time Frame: 20 days
applying culture and sensitivity tests for patients developed sepsis on admission and follow up will direct us to the proper treatment protocol for all patients.
20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of sepsis in diabetics versus non diabetics in ICU.
Time Frame: 15 days
Asses the effect of hyperglycemia on sepsis outcomes.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Sepsis in ICU.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on culture from infected site

Subscribe