Clinical trial NCT02779933: Epidemiology of Risk Factors for Hospital-acquired Pneumonia (HAP) in Intensive Care Unit (ICU) Patients
Official title: Epidemiology of Risk Factors for Hospital-acquired Pneumonia in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Associated Pneumonia
Keywords: Hospital-acquired Pneumonia
Epidemiology
Risk Factors
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality (non modifiable HAP risk factor)
timeFrame: 30 days
Secondary outcomes:
measure: Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Repeated transport of the patient from the ICU (non modifiable HAP risk factor)
timeFrame: 30 days
measure: Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Bronchoscopy before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Sedation administration before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)
timeFrame: 7 days
measure: Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Diabetes mellitus before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Ischemic heart disease before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Hypertension before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
measure: Multi-organ failure before onset of HAP (modifiable HAP risk factor)
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: UH Olomouc, Czech Republic
name: Radovan Uvizl
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.