Intensive Care Unit Procedure Related Infections

January 14, 2024 updated by: Mostafa Farouk, Cairo University

Procedure Related Infections in Intensive Care Unit

Objectives: To identify the rate and predictors of procedure related infection, the most causative organisms and the effect on ICU stay and in hospital mortality. To show the validity of NEW score in predicting mortality.

Methods: Prospective observational study of 1040 patients admitted to the ICU without any signs of infection. All patients were subjected to one or more of the most used procedures in ICU (Intubation & mechanical ventilation, Central line insertion and Urinary catheterization) for at least 48 hours. Then, they were followed for any signs of infection either clinically or laboratorial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AIM OF THE WORK

  • To identify the rate and predictors of procedure related infections in ICU after application of all preventive measures and to identify most causative organisms.
  • Identification of the effect of procedure related infections on ICU stay and in hospital mortality.
  • To study the validity of NEW score in predicting mortality in comparison to APACHE II score .

PATIENTS AND METHODS

Study design:

This was a prospective observational study carried out at medical and cardiac intensive care units (ICUs) of 3 secondary and tertiary care hospitals from July 2022 to June 2023 and included 1040 patients.

Inclusion criteria:

All consecutive adult patients admitted to ICU who had been subjected to the following procedures:

  1. Urinary catheterization.
  2. Central venous catheter (CVC) insertion.
  3. Endotracheal intubation and mechanical ventilation.

Exclusion criteria:

  • Patients with evidence of infection prior to ICU admission.
  • Procedures done before ICU admission.

All patients were subjected to the following assessment:

A) On admission:

  • The acute physiology and chronic health evaluation II (APACHE II) score.
  • New early warning score 2 (NEWS2): NEWS ranges from 0, indicating the lowest severity of illness, to a maximum value of 20.
  • Detailed history including age, sex, medical history.
  • Complete clinical examination.
  • Chest x-ray.

B) ICU stay:

• Laboratory investigations include Complete blood count (CBC), C reactive protein (CRP), renal and liver chemistry after 2, 4, 6, 12, 18 and 24 days.

Blood, urine and sputum cultures if infection was suspected.

• Chest x-ray if chest infection suspected.

C) FOLLOW UP :

  • Length of mechanical ventilation
  • Length of ICU stay
  • Length of hospital stay
  • Morbidity & mortality

Primary outcomes:

  1. Identification of rate and predictors of procedure related infections.
  2. Identification of the most causative organisms.

Secondary outcomes:

  1. Identification of the effect of procedure related infections on ICU stay and in hospital mortality.
  2. The validity of NEW score in predicting mortality

Definitions:

Ventilator associated pneumonia (VAP): was defined as pneumonia occurring >48 hours following endotracheal intubation when a new or progressive lung infiltrates, consolidation, or cavitation on chest X-ray develops in a patient with:

  • New onset of purulent bronchial secretions with leukopenia (white blood cells <4×109/L) or leukocytosis (>12×109/L)
  • Core temperature ≥38.5°C or ≤36°C without other cause, significant positive culture from blood, or endotracheal aspirate, broncho-alveolar lavage (BAL), or culture from another relevant site of infection [10].

Catheter associated urinary tract infection (CAUTI): A patient must meet all three criteria below:

  1. Patient had an indwelling urinary catheter that had been in place for >2 days on the date of event (day of device placement=day 1) and was either present for any portion of the calendar day on the date of event or removed the day before the date of event.

  2. Patient has at least one of the following signs or symptoms:

    fever (>38.0°C); suprapubic tenderness; costovertebral angle pain or tenderness; urinary urgency; urinary frequency; dysuria.

  3. Patient has a urine culture with no more than two species of organisms identified, at least one of which is a bacterium of ≥105 cfu/mL.

Central line associated blood stream infection (CLABSI): A patient with a central venous catheter who has a recognized pathogen isolated from one or more blood cultures after 48 h of catheterization; or with the same skin commensals cultured from two or more blood cultures drawn on separate occasions; the pathogen is not related to an infection at another body site; and the patient has one or more of the following signs or symptoms: fever (≥38⁰c), chills, or hypotension, CLABSI was confirmed.

Statistical analysis SPSS 26.0 (SPSS Inc., an IBM Company, Chicago, IL) was used to perform the data analyses.

Baseline differences among rates were analyzed using the chi-square test for dichotomous variables and a t-test for continuous variables. 95% confidence intervals (CIs) and P values were determined for all outcomes.

Outcomes measured during the surveillance period included the incidence of overall DAIs, VAPs, CAUTIs, and CLABSIs.

DAI rates per 1,000 device-days were calculated by dividing the total number of DAIs by the total number of specific device-days and multiplying the result by 1,000 (16).

Device utilization ratios were calculated by dividing the total number of device-days by the total number of patient-days.

Device-days are the total number of days of exposure to the device (ventilator, urinary catheter, or central line) by all of the patients in the selected population during the selected time period.

Patient-days are the total number of days that patients are in an ICU during the specified time period.

Discrimination of scoring systems was assessed using the receiver operating characteristic (ROC) curve analysis for calculating the sensitivity and specificity of each score and the corresponding area under the ROC curve.

Correlations between quantitative variables were done using Spearman correlation coefficient.

Crude excess mortality of DA-HAI equals crude mortality of ICU patients with DA-HAI minus crude mortality of patients without DA-HAI.

Crude excess LOS of DA-HAI equals crude LOS of ICU patients with DA-HAI minus crude LOS of patients without DA-HAI.

Qualitative variables were presented as number and percentage (%).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1040

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11345
        • Cairo university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all ppopulations

Description

Inclusion Criteria:

  • All consecutive adult patients admitted to ICU who had been subjected to the following procedures:

    1. Urinary catheterization.
    2. Central venous catheter (CVC) insertion.
    3. Endotracheal intubation and mechanical ventilation.

Exclusion Criteria:

  • • Patients with evidence of infection prior to ICU admission.

    • Procedures done before ICU admission.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of rate and predictors of procedure related infections
Time Frame: 3 months
  1. Identification of rate and predictors of procedure related infections.
  2. Identification of the most causative organisms
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1. Identification of the effect of procedure related infections on ICU stay and in hospital mortality.
Time Frame: 3 months
2. The validity of NEW score in predicting mortality.
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahmed Mowafy, MD, Cairo university

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kasr alainy school of medicine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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