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Completed

NCT Number: NCT02779933

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidemiology od HAP

Other

no intervention

Primary outcomes

  1. 30-day mortality (non modifiable HAP risk factor)

    Time frame: 30 days

    Yes/No assessment

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Implementation of physiotherapy before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Assessment if physiotherapy was provided or not

  5. Intolerance of enteral nutrition before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  6. Nasogastric intubation before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  7. Bronchoscopy before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  8. Sedation administration before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  9. Urgent tracheal intubation before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  10. Tracheal reintubation before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  11. Aspiration into the lungs before onset of HAP (non modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  12. Condition after abdominal surgery or thoracotomy before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

  13. Condition after head trauma or neurosurgery before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  14. Condition after tracheotomy before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  15. Impaired consciousness with Glasgow coma scale low than 8 before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  16. Immunosuppression or leukopenia less than 1.5x10 9/L before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  17. Chronical Obstructive Pulmonary Disease before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  18. Diabetes mellitus before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  19. Acute renal insufficiency without renal replacement therapy before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  20. Acute renal insufficiency with renal replacement therapy before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  21. Chronic renal insufficiency before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  22. Ischemic heart disease before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  23. Hypertension before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

  24. Multi-organ failure before onset of HAP (modifiable HAP risk factor)

    Time frame: 7 days

    Yes/No assessment

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

Epidemiology of Risk Factors for Hospital-acquired Pneumonia in ICU Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 23, 2016
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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