The BioVent - BIOmarkers for mechanically VENTilated patients cohort study
| ISRCTN | ISRCTN59376582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59376582 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/07/2013
- Registration date
- 31/10/2013
- Last edited
- 20/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland
Study information
| Study design | Investigator initiated and driven prospective observational multicentric longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective, multicentric, longitudinal study to determine predictors of outcome in mechanically ventilated critically ill patients |
| Study acronym | BioVENT |
| Study objectives | 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(s) | 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 dethique 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2011 |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 (500 derivation cohort, 500 confirmation cohort) |
| Total final enrolment | 961 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Patients with pre-existing mental disorder precluding proper informed consent |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/04/2015 |
Locations
Countries of recruitment
- Austria
- France
- Switzerland
Study participating centre
4031
Switzerland
Sponsor information
Hospital/treatment centre
Dept of Pneumology
Petersgraben 4
Basel
4031
Switzerland
| Website | http://www.unispital-basel.ch/ |
|---|---|
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Other non-profit organizations
- Alternative name(s)
- University Hospital Basel, University Hospital of Basel, The University Hospital Basel, Hôpital Universitaire de Bâle, L’Hôpital universitaire de Bâle, Das Universitätsspital Basel, UHB
- Location
- Switzerland
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- UniBas, University of Basel, Universitas Basiliensis, Die Universität Basel, UB
- Location
- Switzerland
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/04/2023 | 20/04/2023 | Yes | No |
Editorial Notes
20/04/2023: Publication reference and total final enrolment added.
24/07/2020: No publications found.
