Epidemiology of Risk Factors for Hospital-acquired Pneumonia (HAP) in Intensive Care Unit (ICU) Patients

May 18, 2016 updated by: Radovan Uvizl, University Hospital Olomouc

Epidemiology of Risk Factors for Hospital-acquired Pneumonia in ICU Patients

A retrospective, observational study compiled data from all consecutively admitted patients older than 18 years at ICU University Hospital in Olomouc in the period from 1 January 2011 to 31 December 2015 who fulfilled the criteria of HAP. The aim was to determine the severity of the specific risk factors of early and late HAP. Risk factors were divided into factors from the patient and from the hospitalization. Furthermore, an assessment of their relationship to mortality.

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

The primary outcome was to evaluate the relationship between risk factors and the development of early/late onset HAP. Another outcome was assessed to evaluate the relation of risk factors early/late onset HAP and mortality. The crucial time for evaluating the presence of risk factors was their presence from hospital admission to the moment of fulfilling the criteria for pneumonia. Risk factors were divided into two groups, on factors of the patient (uncontrollable) and by the hospitalization (controllable). Factors of the patient were: gender (male/female), age at enrollment (years), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, multi-organ failure presence (MOF), hypertension, ischemic heart disease (IHD) chronic renal insufficiency (CRI), continual use of renal replacement therapy (CRRT), acute renal insufficiency (ARI), diabetes mellitus (DM), Chronical Obstructive Pulmonary Disease (COPD), immunosuppression or leukopenia <1.5x109/l, impaired consciousness with Glasgow coma scale (GCS) <8 tracheotomy, head trauma/neurosurgery, abdominal surgery-thoracotomy. Side factors hospitalization were: aspiration into the lungs, urgent intubation, reintubated, sedation, bronchoscopy, nasogastric intubation, enteral feeding continuously/intermittently intolerance of enteral nutrition, physiotherapy, repeated transport of the patient from the ICU, length of hospital stay, length of mechanical ventilation, 30-day mortality.

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.
310

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study included patients hospitalized in the ICU Department of Anesthesiology and Intensive Care Medicine, UH Olomouc. On inclusion did not affect the method of ensuring lower airways (invasive/non-invasive) or results (positivity/negativity) taken microbiological samples from the lower airways (endobronchial aspirate or bronchoalveolar lavage) as approximately one third of samples can be microbiologically negative even when overt bronchopneumonia. Patient cohort consisted of all patients older than 18 years who met the clinical criteria and HAP were consecutively admitted to the ICU.

Description

Inclusion Criteria:

  • Hospital-Acquired Pneumonia
  • Intensive Care patient
  • X-ray signs of pneumonia

Exclusion Criteria:

  • Age less than 18 years
  • Negative culture findings in the airways
  • Low quantity of culture findings

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
30-day mortality (non modifiable HAP risk factor)
Time Frame: 30 days
Yes/No assessment
30 days

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
Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Assessment if mechanical ventilation was provided, or for how long
7 days
Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Assessment if hospital stay was present, or for how long
7 days
Repeated transport of the patient from the ICU (non modifiable HAP risk factor)
Time Frame: 30 days
Assessment if repeated transports were present or not
30 days
Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Assessment if physiotherapy was provided or not
7 days
Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Bronchoscopy before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Sedation administration before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
7 days
Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Diabetes mellitus before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Ischemic heart disease before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Hypertension before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days
Multi-organ failure before onset of HAP (modifiable HAP risk factor)
Time Frame: 7 days
Yes/No assessment
7 days

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.
University Hospital Olomouc

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.
  • Principal Investigator: Radovan Uvizl, UH Olomouc, Czech Republic

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

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.
January 1, 2011

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.
December 1, 2015

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.
May 1, 2016

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).
May 12, 2016

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.
May 18, 2016

First Posted (Estimate)

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.
May 23, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
May 23, 2016

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.
May 18, 2016

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.
May 1, 2016

More Information

Terms related to this study

Keywords

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.
  • 63/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Collecting data from individual patients medical documentation

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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