- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779933
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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