Biomarkers in Patients Undergoing Mechanical Ventilation

NCT02078999 | Completed

• 2 other identifiers: Ventilator-adquired PneumoniaVAP2008
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Ventilator Associated Pneumonia

Keywords

Mechanical ventilation, procalcitonin, c-reactive protein

Outcome Measures

Primary Outcomes (1)

• Procalcitonine (PCT) levels evolution

  Procalcitonin (PCT) levels assessed daily up to 21 days

  Up to 21 days

Secondary Outcomes (2)

• C-Reactive Protein (CRP)

  Up to 21 days

• Biomarkers at day of Ventilator-Adquired Pneumonia (VAP)

  Up to 21 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted in the ICU

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Hospital Universitari Vall d'Hebron Research Institute: collaborator
• Hospital Clinic of Barcelona: collaborator
• Centro Hospitalar Lisboa Ocidental: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (4)

• 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.

  PMID: 27076187 RESULT

• Martin-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.

  PMID: 26377207 RESULT

• Ceccato 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.

  PMID: 37893050 DERIVED

• 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. 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.

  PMID: 28502892 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalveolar lavage,biochemical lab,exhaled air.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• torres antonio, doctor

  hospital vall hebron barcelona

  PRINCIPAL INVESTIGATOR

• palomar mercedes, doctor

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

• povoa pedro, doctor

  Centro hospitalario de lisboa occidental

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: March 5, 2014
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

ES (1)