Development of a warning system for circulatory instability in critically ill patients
| ISRCTN | ISRCTN10657654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10657654 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2018-00232 |
| Sponsor | Edwards Lifesciences (Switzerland) |
| Funder | Edwards Lifesciences |
- Submission date
- 27/01/2021
- Registration date
- 02/02/2021
- Last edited
- 01/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and Study Aims
Monitoring Cardiac ouptut is essential to treat patients with shock in the intensive care unit. The aim of this study is to improve short term detection of changes in cardiac output by means of a software algorithm with data from pulmonary artery cathter
Who can participate?
Adult patients with shock and a pulmonary artery catheter at the University Hospital Bern (Switzerland)
What does the study involve?
This observational study only collects routinely collected data. No additional study-specific measures are taken
What are the possible benefits and risks of participating?
None
Where is the study run from?
University Hospital Bern (Switzerland)
When is the study starting and how long is it expected to run for?
October 2017 to December 2021
Who is funding the study?
Edwards Lifesciences (Switzerland)
Who is the main contact?
Dr David Berger, david.berger@insel.ch
Contact information
Scientific
Department of Intensive Care Medicine
Inselspital
University Hospital Bern
Bern
3010
Switzerland
 ORCID ID |
0000-0003-0705-6341 |
|---|---|
| Phone | +41 31 632 5079 |
| david.berger@insel.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single center observational study |
| Secondary study design | Cohort study |
| Scientific title | Pulmonary artery pulse contour analysis in critically ill patients |
| Study objectives | The primary objective of this analysis is the evaluation of pulmonary artery pulse contour analysis to detect trends in cardiac output and pulmonary artery resistance and elastance. After establishing a routine for pulse contour analysis, respective stroke volumes will be compared with intermittent and continuous cardiac output. |
| Ethics approval(s) | Approved 06/04/2018, Ethics Committee of the Swiss Canton of Bern (Kantonale Ethikkomission für die Forschung, Gesundheits- und Fürsorgerdirekton des Kanton Bern, Murtenstrasse 31, CH- 3010 Bern Switzerland; + 41 31 633 70 70; info.kek.kapa@gef.be.ch), ref: 2018-00232 |
| Health condition(s) or problem(s) studied | Shock |
| Intervention | Patients are eligible for the observational trial when they are monitored in the ICU by a pulmonary artery catheter. Hemodynamic data will be collected in real time for a period of 24 hours in addition to lab and clinical data. No specific interventions relate to the trial. The observation period is 24 hours maximum or until removal of the pulmonary artery catheter. |
| Intervention type | Other |
| Primary outcome measure(s) |
Cardiac stroke volume measured using the pressure trace of the pulmonary artery collected using 24 hour ECG |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | Adult patients (age >= 18 years) treated on the participating intensive care unit for shock of any etiology monitored with a pulmonary artery catheter are eligible for inclusion |
| Key exclusion criteria | 1. Patients/next of kin refusing to provide general consent 2. Mother tongue different from available general consent forms 3. Known pregnancy or breastfeeding 4. Patients institutionalized in correctional facilities 5. Patients institutionalized in psychiatric institutions |
| Date of first enrolment | 08/06/2018 |
| Date of final enrolment | 21/12/2021 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Inselspital
Freiburgstrasse
Bern
3010
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
01/02/2021: Trial’s existence confirmed by Ethics Committee of the Swiss Canton of Bern.
