Condition category
Respiratory
Date applied
05/07/2013
Date assigned
31/10/2013
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The predictive properties of biomarkers in critical care are promising. However, there are few studies and most prospective studies are restricted to specific diseases. The aim of this study is to explore predictors of outcomes in mechanically ventilated patients; to assess short-term and long-term outcomes of mechanically ventilated patients; to identify major events during mechanical ventilation; to identify chronic diseases associated with poor outcomes; to analyze the potential and verify previous results of circulating biomarkers for prognostication in mechanically ventilated patients, patients with ventilator-associated pneumonia and patients with prolonged mechanical ventilation

Who can participate?
Critically ill patients requiring invasive mechanical ventilation for at least 12 hours.

What does the study involve?
This is an observational study. The study does not interfere with treatment. Besides additional blood sampling no interventions are planned. Patients will be assessed at study inclusion, after two, four days, at ICU discharge, at hospital discharge and after one year. Further assessments are scheduled if ventilator-associated pneumonia is suggested or the patient is continuously on invasive mechanical ventilation for 21 days.

What are the possible risks and benefits of participating?
Patients do not experience any direct benefits from the study. However, they contribute to the improvement of medical knowledge in the field. Patients are exposed to a marginal increased risk of anaemia, due to additional blood sampling (approx. 30ml blood, at most 100ml blood during the whole study).

Where is the study run from?
University Hospital Basel, Clinic of Pulmonary Medicine and Respiratory Cell Research (Switzerland)

When is the study starting and how long is it expected to run for?
The study started in 2011 and is expected to last four and half years. The trial will be recruiting participants for approximately three and an half years

Who is funding the study?
University Hospital Basel, Clinic of Pneumology and Respiratory Cell Research. Unrestricted grants are provided by the Gottfried und Julia Bangerter-Rhyner Foundation, University Basel and Freie Akademische Foundation (Switzerland).

Who is the main contact?
Prof. Daiana Stolz

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective, multicentric, longitudinal study to determine predictors of outcome in mechanically ventilated critically ill patients

Acronym

BioVENT

Study hypothesis

Circulating biomarkers are able to reliably identify patients with poor outcomes among a critically ill population requiring mechanical ventilation in medical and surgical ICUs.

Ethics approval

1. Basel Ethics Committee (Ethikkomission beider Basel 03/2010), Ref.Nr EK 75/10
2. Bellinzona Ethics Committee (Comitato etico cantonale Bellinzona) 12/2011, Rif.CE 2519
3. Lausanne Ethics Committee (Commission cantonale d’ethique Lausanne) 03/2011, Protocole 65/11
4. Medical University of Vienna Ethics Committee (Ethikkomission der Medizinischen Universität Wien) 01/2012, EK Nr. 946/2011
5. Zurich Ethics Committee (Kantonale Ethik-Komission Zürich) 01/2012, KEK-ZH-Nr. 2011-0326
6. Ile de France VI Ethics Committee (Comité de Protection des Personnes Ile de France VI)

Study design

Investigator initiated and driven prospective observational multicentric longitudinal study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Critically ill patients on invasive mechanical ventilation

Intervention

Visit day 0: assessment of baseline characteristics, vitals, venous puncture, subjective estimation of outcome
Visit day 2: vitals, venous puncture, subjective estimation of outcome
Visit day 4: vitals, venous puncture, subjective estimation of outcome
Visit ICU discharge: assessment of complications during ICU stay
Visit hospital discharge: assessment of survival
Visit 1 year: assessment of survival
Visit VAP (if patient develops ventilator associated pneumonia during ICU stay): assessment of VAP parameters, vitals, venous puncture, subjective estimation of outcome
Visit VAP day 4 (four days after development of ventilator associated pneumonia): vitals, venous puncture, subjective estimation of outcome
Visit PMV (if patient on invasive mechanical ventilation for 21 days, prolonged mechanical ventilation) day : vitals, venous puncture, subjective estimation of outcome

Follow-up duration: 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Crude mortality within 28 days

Secondary outcome measures

1. Mortality within one year
2. Duration of ICU and hospital stay
3. Duration of mechanical ventilation, ventilation free days, weaning attempts, survival in the subgroups of mechanically ventilated patients, events during mechanical ventilation

Endpoints will be obtained during ICU stay or at scheduled assessments.

Overall trial start date

01/04/2011

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Critically ill patients at the start of invasive mechanical ventilation
2. Estimated to require continuous ventilatory support for longer than 24 hours or if already ventilated for 12 to maximal 36 hours.
3. 18 years of age or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000 (500 derivation cohort, 500 confirmation cohort)

Participant exclusion criteria

1. Pregnancy
2. Patients with pre-existing mental disorder precluding proper informed consent

Recruitment start date

01/04/2011

Recruitment end date

01/04/2015

Locations

Countries of recruitment

Austria, France, Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Dept of Pneumology
Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.unispital-basel.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gottfried und Julia Bangerter-Rhyner-Stiftung (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Basel (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Freie Akademische Stiftung (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes