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

Completed

• Conditions: Ventilator-Associated Pneumonia

• Registration Number: NCT02779933
• Lead Sponsor: University Hospital Olomouc

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2015-12
• Status Verified: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-23
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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