Ventilator-Associated PneumoniaNCT02779933
Epidemiology of Risk Factors for Hospital-acquired Pneumonia (HAP) in Intensive Care Unit (ICU) Patients
An observational study of Ventilator-Associated Pneumonia, run by University Hospital Olomouc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia
- What is being tested?
- Epidemiology od HAP
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hospital-Acquired Pneumonia
- Intensive Care patient
- X-ray signs of pneumonia
Who cannot join
- Age less than 18 years
- Negative culture findings in the airways
- Low quantity of culture findings
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventilator-Associated Pneumonia
- Being tested
- Epidemiology od HAP
- Keywords
- Hospital-acquired Pneumonia, Epidemiology, Risk Factors
- Medical subject headings
- Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiology od HAPOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality (non modifiable HAP risk factor)
Yes/No assessment
Measured: 30 days
Secondary outcomes (24)
Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)
Assessment if mechanical ventilation was provided, or for how long
Measured: 7 days
Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)
Assessment if hospital stay was present, or for how long
Measured: 7 days
Repeated transport of the patient from the ICU (non modifiable HAP risk factor)
Assessment if repeated transports were present or not
Measured: 30 days
Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)
Assessment if physiotherapy was provided or not
Measured: 7 days
Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Bronchoscopy before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Sedation administration before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)
Measured: 7 days
Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Diabetes mellitus before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Ischemic heart disease before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Hypertension before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Multi-organ failure before onset of HAP (modifiable HAP risk factor)
Yes/No assessment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radovan Uvizl, University Hospital Olomouc
- Investigators
- Radovan Uvizl, Principal investigator, UH Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779933
- Sponsor's protocol ID
- 63/16
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Collecting data from individual patients medical documentation
Publications
Uvizl R, Kolar M, Herkel T, Vobrova M, Langova K. Possibilities for modifying risk factors for the development of hospital-acquired pneumonia in intensive care patients: results of a retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Sep;161(3):303-309. doi: 10.5507/bp.2017.019. Epub 2017 Apr 26.
PubMed 28461706
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Risk Factors for Hospital-acquired Pneumonia in ICU Patients
- ClinicalTrials.gov ID
- NCT02779933
- Acronym / sponsor ID
- 63/16
- Conditions
- Ventilator-Associated Pneumonia
- Keywords
- Hospital-acquired Pneumonia, Epidemiology, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Hospital-Acquired Pneumonia
- Intensive Care patient
- X-ray signs of pneumonia
Key exclusion criteria (3 listed)
- Age less than 18 years
- Negative culture findings in the airways
- Low quantity of culture findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiology od HAPno intervention | Other | – |
Primary outcome
30-day mortality (non modifiable HAP risk factor)
Time frame: 30 days
Yes/No assessment
24 secondary outcomes
Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Repeated transport of the patient from the ICU (non modifiable HAP risk factor)
Time frame: 30 days
Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Bronchoscopy before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Sedation administration before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)
Time frame: 7 days
Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Diabetes mellitus before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Ischemic heart disease before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Hypertension before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Multi-organ failure before onset of HAP (modifiable HAP risk factor)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Derived from this study: PubMed 28461706Uvizl R, Kolar M, Herkel T, Vobrova M, Langova K. Possibilities for modifying risk factors for the development of hospital-acquired pneumonia in intensive care patients: results of a retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Sep;161(3):303-309. doi: 10.5507/bp.2017.019. Epub 2017 Apr 26.
- Individual participant dataSharing planned: Yes. Collecting data from individual patients medical documentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Uvizl principal investigator
UH Olomouc, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Pneumonia, run by University Hospital Olomouc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (non modifiable HAP risk factor) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.