Development of a warning system for circulatory instability in critically ill patients

ISRCTN	ISRCTN10657654
DOI	https://doi.org/10.1186/ISRCTN10657654
Secondary identifying numbers	2018-00232

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr David Berger
Scientific

Department of Intensive Care Medicine
Inselspital
University Hospital Bern
Bern
3010
Switzerland

ORCID ID	0000-0003-0705-6341
Phone	+41 31 632 5079
Email	david.berger@insel.ch

Study information

Study design	Single center observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
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	Cardiac stroke volume measured using the pressure trace of the pulmonary artery collected using 24 hour ECG
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	01/10/2017
Completion date	31/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1,000
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

University Hospital Bern

Department of Intensive Care Medicine
Inselspital
Freiburgstrasse
Bern
3010
Switzerland

Sponsor information

Edwards Lifesciences (Switzerland)
Industry

Route de l'Etraz 70
Nyon
1260
Switzerland

Phone	+41 22 787 43 00
Email	Teju_Chaugule@edwards.com
Website	http://www.edwards.com/ch-en
"ROR"	https://ror.org/012fexm34

Funders

Funder type

Industry

Edwards Lifesciences
Government organisation / For-profit companies (industry)

Alternative name(s): Edwards, Edwards Lifesciences Corporation, Edwards Lifesciences Corp., Edwards Lifesciences LLC, ELC
Location: United States of America

Results and Publications

Intention to publish date	31/12/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
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.