Condition category
Circulatory System
Date applied
06/09/2010
Date assigned
28/10/2010
Last edited
28/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Urs Wenger

ORCID ID

Contact details

University Hospital Zürich
Rämistrasse 100
Zürich
8091
Switzerland

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

http://www.imk.ch/Intro/WebHome

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

Publication citations

Additional files

Editorial Notes