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

Completed

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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

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

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.

Investigators

  • 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.

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

January 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

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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