Condition category
Circulatory System
Date applied
16/01/2015
Date assigned
04/02/2015
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Extravascular lung water refers to fluid within the lung. Increase in extravascular lung water is associated with death in very ill patients. The purpose of this study is to compare three methods of lung ultrasound with transpulmonary thermodilution technique.

Who can participate?
Individuals with septic shock, 18 years old or over

What does the study involve?
All patients will be assessed with three methods of lung ultrasound (total B-line scores, BLUE points and scanning eight regions) and the results will be compared with the transpulmonary thermodilution technique.

What are the possible benefits and risks of participating?
A benefit is improvement in the monitoring of the patients. The risks are bleeding, haematoma and pneumothorax.

Where is the study run from?
Phramongkutklao Hospital (Thailand)

When is study starting and how long is it expected to run for?
From March 2013 to July 2014

Who is funding the study?
Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage (Thailand)

Who is the main contact?
Dr. Pattarin Pirompanich

Trial website

Contact information

Type

Public

Primary contact

Dr Pattarin Pirompanich

ORCID ID

http://orcid.org/0000-0003-0181-5394

Contact details

Division of Pulmonary and Critical Care Medicine
Department of Internal Medicine
Faculty of Medicine
Thammasat University
Klong 1
Klong Luang
Pathumthani
12120
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of three methods of lung ultrasound with the transpulmonary thermodilution technique for assessment of extravascular lung water in patients with septic shock

Acronym

Study hypothesis

Extravascular lung water index greater than 10 mL/kg in patients with cardiogenic pulmonary oedema correlates with pulmonary capillary wedge pressure of greater than 20 mm Hg. Measurement of extravascular lung water needs sophisticated tools and use of the invasive transpulmonary thermodilution technique. By contrast, multiple B-lines by transthoracic portable ultrasound have been recently proposed to correlate with increased extravascular lung water in patients with cardiogenic pulmonary oedema.

Lung ultrasound has a good correlation with transpulmonary thermodilution technique for the assessment of extravascular lung water in patients with septic shock.

Ethics approval

Institutional review board of the Royal Thai Army Medical Department, 22/04/2009
Reference number: R032h/56

Study design

Cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Septic shock

Intervention

1. Total B-line scores
2. BLUE points
3. Scanning eight regions
These three methods of lung ultrasound were used on each patient to assess extravascular lung water and the results were compared with those from obtained with the transpulmonary thermodilution technique.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Best method of lung ultrasound to diagnose pulmonary oedema in patients with septic shock: cutoff point of extravascular water index measured by transpulmonary thermodilution greater than
10 mL/kg predicted bodyweight, which is correlated with a pulmonary capillary wedge pressure of greater than 20 mmHg to indicate pulmonary oedema

Secondary outcome measures

Cutoff point of total B-line scores to predict extravascular lung water index of 10 mL/kg or more

Overall trial start date

01/03/2013

Overall trial end date

30/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years old or over
2. Septic shock requiring central venous catheterisation and arterial catheterisation for continuous pressure monitoring

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 comparisons from 17 patients

Participant exclusion criteria

1. Valvular heart disease
2. Pregnancy
3. Acute or history of pulmonary embolism
4. Lung resection surgery
5. Acute respiratory distress syndrome
6. Interstitial lung diseases
7. Mulitilobar pneumonia
8. Pleural diseases

Recruitment start date

01/09/2013

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Thailand

Trial participating centre

Phramongkutklao Hospital
315 Phayathai Road Ratchathewi
Bangkok
10400
Thailand

Sponsor information

Organisation

Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage

Sponsor details

315 Phayathai Road
Ratchathewi
ฺBangkok
10400
Thailand
+6623543699
foundation_pmk@hotmail.com

Sponsor type

Charity

Website

http://www.foundation.pmk.ac.th/index.html

Funders

Funder type

Charity

Funder name

Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publish the results in a few months

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/10/2016: internal review.