NCT02779933

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

4.9 years

First QC Date

May 12, 2016

Last Update Submit

May 18, 2016

Conditions

Keywords

Hospital-acquired PneumoniaEpidemiologyRisk Factors

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality (non modifiable HAP risk factor)

    Yes/No assessment

    30 days

Secondary Outcomes (24)

  • Duration of mechanical ventilation before onset of HAP (non modifiable HAP risk factor)

    7 days

  • Duration of hospital stay before onset of HAP (non modifiable HAP risk factor)

    7 days

  • Repeated transport of the patient from the ICU (non modifiable HAP risk factor)

    30 days

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

    7 days

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

    7 days

  • +19 more secondary outcomes

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Hospital-Acquired Pneumonia
  • Intensive Care patient
  • X-ray signs of pneumonia

You may not qualify if:

  • Age less than 18 years
  • Negative culture findings in the airways
  • Low quantity of culture findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

endotracheal aspirate

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Radovan Uvizl

    UH Olomouc, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MUDr., Ph.D.

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 23, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

May 23, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Collecting data from individual patients medical documentation