Assessment of lung water in patients with low blood pressure after infection
| ISRCTN | ISRCTN11419081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11419081 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/01/2015
- Registration date
- 04/02/2015
- Last edited
- 09/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Division of Pulmonary and Critical Care Medicine
Department of Internal Medicine
Faculty of Medicine
Thammasat University
Klong 1
Klong Luang
Pathumthani
12120
Thailand
 ORCID ID |
0000-0003-0181-5394 |
|---|
Study information
| Study design | Cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| 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 |
| Study objectives | 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(s) | Institutional review board of the Royal Thai Army Medical Department, 22/04/2009 Reference number: R032h/56 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/03/2013 |
| Completion date | 30/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 comparisons from 17 patients |
| Key inclusion criteria | 1. Age 18 years old or over 2. Septic shock requiring central venous catheterisation and arterial catheterisation for continuous pressure monitoring |
| Key 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 |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Ratchathewi
Bangkok
10400
Thailand
Sponsor information
Charity
315 Phayathai Road
Ratchathewi
ฺBangkok
10400
Thailand
| Phone | +6623543699 |
|---|---|
| foundation_pmk@hotmail.com | |
| Website | http://www.foundation.pmk.ac.th/index.html |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Publish the results in a few months |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2018 | Yes | No |
Editorial Notes
09/10/2018: Publication reference added.
20/10/2016: internal review.
