Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective multicentre study to investigate the prevalence, causes, diagnostic and therapeutic approach of pulmonary hypertension in the Intensive Care Unit (ICU)
Acronym
PHICUSS1
Study hypothesis
To investigate the prevalence, causes, diagnostic and therapeutic approach of pulmonary hypertension (PH) of any cause in the setting of surgical, medical or interdisciplinary Intensive Care Units (ICUs) of primary, secondary and tertiary Swiss hospitals.
Ethics approval
Ethics approval was not required for this study.
Study design
Prospective multicentre study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pulmonary hypertension
Intervention
The current characteristics, local facilities, diagnostic and therapeutic attitude against PH of the participating ICUs are assessed prior to study beginning by a questionnaire (hospital form).
During the study period all consecutive patients admitted to ICU for any reason are screened for presence or suspicion of PH. If PH is present or suspected the most probable causes, diagnostic and therapeutic attitude, clinical, laboratory, haemodynamic data (if measured) and 30 days survival will be assessed by a questionnaire (patient form).
Participating centres are asked to complete the hospital form only once, before study begin. Thereafter, during the enrolment period all patients admitted to the participating ICU are screened by use of the patient from. Only if PH is present, suspected or disclosed at ICU admission, or if risk factors for PH were present, additional information will be requested.
Data collection will be performed online using an electronic form of the data collection sheet.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Prevalence of PH of any cause in the setting of surgical, medical or interdisciplinary ICUs. During the planned study period of 2 weeks enrolment of about 1000 patients is expected. It is a cross-sectional survey, only follow-up is 30 day mortality.
Secondary outcome measures
1. Causes of PH in the ICU setting
2. Diagnostic and therapeutic approach to PH by Swiss ICU physicians
3. 30 day outcome of patients admitted to ICU with suspected or confirmed PH
During the planned study period of 2 weeks enrolment of about 1000 patients is expected. It is a cross-sectional survey, only follow-up is 30 day mortality.
Overall trial start date
01/09/2009
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All consecutive patients (no age limit or gender restrictions) admitted to ICU for any reason
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2009
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Zürich
Zürich
8091
Switzerland
Sponsor information
Organisation
Swiss Society of Pulmonary Hypertension (Switzerland)
Sponsor details
c/o Institut für Medizin und Kommunikation (IMK) AG
Münsterberg 1
Basel
4001
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Swiss Society of Intensive Care Medicine (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Actelion Pharma Schweiz AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lung League Ticino (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