Ventilator Associated PneumoniaVAPNCT02078999
Biomarkers in Patients Undergoing Mechanical Ventilation
An observational study of Ventilator Associated Pneumonia, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- How many people
- 211 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2008to Sep 2015
- 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: Patients admitted in the ICU
Who may be able to join
- Patients admitted in the ICU, with an expected length of mechanical ventilation > 3 days.
- Not receiving antibiotics for >24 hrs before ICU admission- An expected length of mechanical ventilation > 3 days
Who cannot join
- Patients <18 yrs old
- Pregnancy and lactation
- Fulminant hepatic failure
- Pancreatitis
- Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study in Patients Admitted in the Intensive Care Unit.Tracheal Bacterial Load Surveillance in Patients Undergoing Mechanical Ventilation - Assessment of Biomarkers in the Distinction Between Colonization and Infection
To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period
Read the detailed description
The investigators hypotized that:
- In patients on mechanical ventilation for a non-infectious cause of respiratory failure, the tracheal bacterial load should be absent or below the cut-off values defined for infection, that is to say tracheal colonization.
- In patients without the diagnosis of Ventilator-Adquired Pneumonia (VAP) and not taking antibiotics till the weaning process, tracheal bacterial load should remain below the predefined cut-off values and the biomarkers (PCT and CRP) should be surrogate markers of this clinical course.
- In patients developing VAP, an increase in tracheal bacterial load should precede diagnosis with an associated rise in the biomarkers levels (PCT and CRP). Finally, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as of the biomarkers (PCT and CRP).
- In patients admitted with clinical suspicion of pneumonia, either community-acquired (CAP) or hospital-acquired (HAP), with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as the biomarkers (PCT and CRP).
- In patients admitted with clinical suspicion of a non-pulmonary infection (e.g. peritonitis and urosepsis) and on mechanical ventilation for an expected length longer than 3 days, either community or hospital-acquired, preferentially with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease of biomarkers (PCT and CRP).
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Mechanical ventilation, procalcitonin, c-reactive protein
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Grup | * Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. | |
| Patients with pulmonary infection | * Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. | |
| Patients with extrapulmonary infection | * Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonine (PCT) levels evolution
Procalcitonin (PCT) levels assessed daily up to 21 days
Measured: Up to 21 days
Secondary outcomes (2)
C-Reactive Protein (CRP)
To evaluate the value of serum C-Reactive Protein (CRP) concentrations in the distinction between colonization and pulmonary infection
Measured: Up to 21 days
Biomarkers at day of Ventilator-Adquired Pneumonia (VAP)
Measurement of biomarkers namely, copeptin, adrenomedulin, atrial natriuretic peptide, Interleukine 6, Interleukine 1 and hydrogen peroxide
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Other
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute, Hospital Clinic of Barcelona, Centro Hospitalar Lisboa Ocidental, Hospital Universitario La Fe
- Responsible party
- Principal investigator, Antonio Artigas Raventós, Corporacion Parc Tauli
- Investigators
- torres antonio, doctor, Principal investigator, hospital vall hebron barcelonapalomar mercedes, doctor, Principal investigator, Hospital Clinic of Barcelonapovoa pedro, doctor, Principal investigator, Centro hospitalario de lisboa occidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078999
- Sponsor's protocol ID
- Ventilator-adquired Pneumonia
- Other IDs
- VAP2008
- Acronym
- VAP
- Status last verified
- Apr 2017
- First submitted
- 3 Aug 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarker kinetics in the prediction of VAP diagnosis: results from the BioVAP study. Ann Intensive Care. 2016 Dec;6(1):32. doi: 10.1186/s13613-016-0134-8. Epub 2016 Apr 14.
PubMed 27076187Martin-Loeches I, Bos LD, Povoa P, Ramirez P, Schultz MJ, Torres A, Artigas A. Tumor necrosis factor receptor 1 (TNFRI) for ventilator-associated pneumonia diagnosis by cytokine multiplex analysis. Intensive Care Med Exp. 2015 Dec;3(1):26. doi: 10.1186/s40635-015-0062-1. Epub 2015 Sep 16.
PubMed 26377207Ceccato A, Camprubi-Rimblas M, Bos LDJ, Povoa P, Martin-Loeches I, Forne C, Areny-Balaguero A, Campana-Duel E, Morales-Quinteros L, Quero S, Ramirez P, Esperatti M, Torres A, Blanch L, Artigas A. Evaluation of the Kinetics of Pancreatic Stone Protein as a Predictor of Ventilator-Associated Pneumonia. Biomedicines. 2023 Sep 29;11(10):2676. doi: 10.3390/biomedicines11102676.
PubMed 37893050Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarkers kinetics in the assessment of ventilator-associated pneumonia response to antibiotics - results from the BioVAP study. J Crit Care. 2017 Oct;41:91-97. doi: 10.1016/j.jcrc.2017.05.007. Epub 2017 May 8.
PubMed 28502892
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Patients Admitted in the Intensive Care Unit.Tracheal Bacterial Load Surveillance in Patients Undergoing Mechanical Ventilation - Assessment of Biomarkers in the Distinction Between Colonization and Infection
- ClinicalTrials.gov ID
- NCT02078999
- Acronym / sponsor ID
- VAP / Ventilator-adquired Pneumonia
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Mechanical ventilation, procalcitonin, c-reactive protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute, Hospital Clinic of Barcelona, Centro Hospitalar Lisboa Ocidental, Hospital Universitario La Fe
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Mar 2014 (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.
To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period
Detailed description
The investigators hypotized that:
- In patients on mechanical ventilation for a non-infectious cause of respiratory failure, the tracheal bacterial load should be absent or below the cut-off values defined for infection, that is to say tracheal colonization.
- In patients without the diagnosis of Ventilator-Adquired Pneumonia (VAP) and not taking antibiotics till the weaning process, tracheal bacterial load should remain below the predefined cut-off values and the biomarkers (PCT and CRP) should be surrogate markers of this clinical course.
- In patients developing VAP, an increase in tracheal bacterial load should precede diagnosis with an associated rise in the biomarkers levels (PCT and CRP). Finally, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as of the biomarkers (PCT and CRP).
- In patients admitted with clinical suspicion of pneumonia, either community-acquired (CAP) or hospital-acquired (HAP), with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as the biomarkers (PCT and CRP).
- In patients admitted with clinical suspicion of a non-pulmonary infection (e.g. peritonitis and urosepsis) and on mechanical ventilation for an expected length longer than 3 days, either community or hospital-acquired, preferentially with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease of biomarkers (PCT and CRP).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Grup | – | –* Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
| Patients with pulmonary infection | – | –* Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
| Patients with extrapulmonary infection | – | –* Daily clinical data collection * Quantitative tracheal aspirates (QTA) every 3 days * Deep freeze serum samples for posterior analysis every day (two aliquots). * In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in the ICU
Key inclusion criteria (2 listed)
- Patients admitted in the ICU, with an expected length of mechanical ventilation > 3 days.
- Not receiving antibiotics for >24 hrs before ICU admission- An expected length of mechanical ventilation > 3 days
Key exclusion criteria (5 listed)
- Patients <18 yrs old
- Pregnancy and lactation
- Fulminant hepatic failure
- Pancreatitis
- Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procalcitonine (PCT) levels evolution
Time frame: Up to 21 days
Procalcitonin (PCT) levels assessed daily up to 21 days
2 secondary outcomes
C-Reactive Protein (CRP)
Time frame: Up to 21 days
Biomarkers at day of Ventilator-Adquired Pneumonia (VAP)
Time frame: Up to 21 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 4 Apr 2017.
- Results publication: PubMed 27076187Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarker kinetics in the prediction of VAP diagnosis: results from the BioVAP study. Ann Intensive Care. 2016 Dec;6(1):32. doi: 10.1186/s13613-016-0134-8. Epub 2016 Apr 14.
- Results publication: PubMed 26377207Martin-Loeches I, Bos LD, Povoa P, Ramirez P, Schultz MJ, Torres A, Artigas A. Tumor necrosis factor receptor 1 (TNFRI) for ventilator-associated pneumonia diagnosis by cytokine multiplex analysis. Intensive Care Med Exp. 2015 Dec;3(1):26. doi: 10.1186/s40635-015-0062-1. Epub 2015 Sep 16.
- Derived from this study: PubMed 37893050Ceccato A, Camprubi-Rimblas M, Bos LDJ, Povoa P, Martin-Loeches I, Forne C, Areny-Balaguero A, Campana-Duel E, Morales-Quinteros L, Quero S, Ramirez P, Esperatti M, Torres A, Blanch L, Artigas A. Evaluation of the Kinetics of Pancreatic Stone Protein as a Predictor of Ventilator-Associated Pneumonia. Biomedicines. 2023 Sep 29;11(10):2676. doi: 10.3390/biomedicines11102676.
- Derived from this study: PubMed 28502892Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarkers kinetics in the assessment of ventilator-associated pneumonia response to antibiotics - results from the BioVAP study. J Crit Care. 2017 Oct;41:91-97. doi: 10.1016/j.jcrc.2017.05.007. Epub 2017 May 8.
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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.
torres antonio, doctor principal investigator
hospital vall hebron barcelona
palomar mercedes, doctor principal investigator
Hospital Clinic of Barcelona
povoa pedro, doctor principal investigator
Centro hospitalario de lisboa occidental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 inclusion and 5 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Procalcitonine (PCT) levels evolution (time frame: Up to 21 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 NCT02078999, which also lists 4 linked publications.
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 4 Apr 2017.