Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000685516
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
1/07/2015
Date last updated
6/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Extra pulmonary Water quantification by PiCCO system in edema reperfusion after pulmonary endarterectomy
Scientific title
Extra pulmonary Water quantification by PiCCO system in edema reperfusion after pulmonary endarterectomy
Secondary ID [1] 285957 0
P14-37815004/SC-14-017
Universal Trial Number (UTN)
U1111-1167-1083
Trial acronym
PiCCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulmonary disease 294254 0
Condition category
Condition code
Surgery 294190 294190 0 0
Other surgery
Respiratory 294571 294571 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Main objective is to study the amount variations of pulmonary water measured by simple thermodilution during the first 48 hours in the intensive care after Pulmonary endarterectomy. The PiCCO-Technology allows monitoring by a minimally invasive method, hemodynamic and volumetric parameters. PiCCO technology is based on transpulmonary thermodilution and contour analysis of the pulse wave. Data thermodilution and analysis of pulse wave are collected using a pulmonary artery catheter and a central venous catheter inserted into the jugular position operating room. A first series of thermodilutions transpulmonary is formed by injection on a center line of the right jugular, three boluses of 15 ml of cold physiological saline solution at 4 degrees Celsius temperature. If there was a difference in cardiac output value of more than 20% between thermodilutions two other thermodilutions are performed. The measured values are the average of three thermodilutions and the extreme values are removed. They also show the values of volumes and analysis of the pulse wave intra-thoracic. Data is collected once a day, an hour after the patient arrival in intensive care unit, and 24 and 48 hours after surgery.

Intervention code [1] 290930 0
Treatment: Other
Comparator / control treatment
Patients were divided according to pulmonary vascular resistance values as severe Chronic thrombo-embolic pulmonary hypertension (pulmonary vascular resistance > 11.25 UW) or non-severe (pulmonary vascular resistance less or equal to 11.25 UW). All patients in both groups underwent pulmonary endarterectomy. No changes in technique or medical management occurred during the study period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293977 0
Study the amount variations of pulmonary water measured by simple thermodilution during the first 48 hours in the intensive care after Pulmonary endarterectomy.

The PiCCO-Technology allows monitoring by a minimally invasive method, hemodynamic and volumetric parameters. PiCCO technology is based on transpulmonary thermodilution and contour analysis of the pulse wave.
Data thermodilution and analysis of pulse wave are collected using a pulmonary artery catheter and a central venous catheter inserted into the jugular position operating room. A first series of thermodilutions transpulmonary is formed by injection on a center line of the right jugular, three boluses of 15 ml of cold physiological saline solution at 4 degrees Celsius temperature. If there was a difference in cardiac output value of more than 20% between thermodilutions two other thermodilutions are performed. The measured values are the average of three thermodilutions and the extreme values are removed. They also show the values of volumes and analysis of the pulse wave intra-thoracic
Timepoint [1] 293977 0
Data is collected once a day, an hour after the patient arrival in intensive care unit, and 24 and 48 hours after surgery.
Secondary outcome [1] 312269 0
The PiCCO System is a device allowing intermittent cardiac output monitoring by aortic transpulmonary thermodilution technique (Aorta intermittent) and continuous cardiac
output monitoring by pulse contour analysis (Aorta continuous).
Timepoint [1] 312269 0
Measurements were obtained at three time, one hour after arrive to ICU and 24 and 48 hours after surgery.
Secondary outcome [2] 313087 0
Analysis the PaO2 / FiO2 ratio variation.

FIO2 was calculated by assuming that it increased by 3% per liter of O2;17 for the nonrebreathing mask with reservoir, FIO2 was assumed to be 80%.
Timepoint [2] 313087 0
Data is collected at three time, one hour after arrive to ICU and 24 and 48 hours after surgery.
Secondary outcome [3] 313088 0
duration of mechanical ventilation
Timepoint [3] 313088 0
Data is collected during the first and second day after surgery.

Eligibility
Key inclusion criteria
It is important that patients respond to following condition:

-hospitalization stay in ICU estimate superior than or equal to 3 days.
- Catheter Swan Ganz functional
- arterial catheter in Femoral position
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Need circulatory and respiratory assistance as ECMO
- Pulmonary endarterectomy failure
- The inability to establish a femoral arterial catheter
- A Swan Ganz catheter nonfunctional

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients were divided according to pulmonary vascular resistance values as severe Chronic thromboembolic pulmonary hypertention (pulmonary vascular resistance > 11.25 UW) or non severe (pulmonary vascular resistance equal to 11.25 UW). All patients in both groups underwent pulmonary endarterectomy . No changes in technique or medical management occurred during the study period.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The comparison of the impact or value judgment criteria between the two groups of patients will be analyzed using conventional methods. Categorical variables will be interpreted using a X2 test, comparing the average with a Student t test.
Univariate analysis factors associated with an amount of lung water> 10mL / kg will be carried out with a logistic regression including changes in pulmonary resistance and an analysis of the correlations between the measured values and continuous water quantity pulmonary in univariate and then the modeling aid.
On the basis of a relevant 30% increase in ELW in patients with severe CTEPH compared with patients without severe CTEPH, we calculated that 30 patients could test the null hypothesis at 0.05 significance with a power of 0.80.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2015
Actual
21/01/2015
Date of last participant enrolment
Anticipated
22/05/2015
Actual
11/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 6678 0
France
State/province [1] 6678 0
Ile de France

Funding & Sponsors
Funding source category [1] 290538 0
Hospital
Name [1] 290538 0
Centre Chirurgical Marie Lannelongue
Country [1] 290538 0
France
Primary sponsor type
Hospital
Name
Centre Chirurgical Marie Lannelongue
Address
133, avenue de la Resistance
92350 Le Plesisi Robinson
Country
France
Secondary sponsor category [1] 289230 0
None
Name [1] 289230 0
NONE
Address [1] 289230 0
NONE
Country [1] 289230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292184 0
Comite de Protection des Personne Ile de France VII
Ethics committee address [1] 292184 0
CHU Bicetre
78, rue du Generale Leclerc
94275 Le Kremlin Bicetre
Ethics committee country [1] 292184 0
France
Date submitted for ethics approval [1] 292184 0
Approval date [1] 292184 0
10/12/2014
Ethics approval number [1] 292184 0

Summary
Brief summary
One of the most common and most serious after pulmonary endarterectomy thromboembolic (PET) complications is edema reperfusion. Monitoring by transpulmonary thermodilution is commonly used in intensive care.
It could allow a quantitative measurement of reperfusion edema by objective measurement and study its possible associations with the hemodynamic and ventilatory parameters.
Trial website
Trial related presentations / publications
The study is terminated and the results are Under evaluation
Public notes

Contacts
Principal investigator
Name 53970 0
Prof Francois STEPHAN
Address 53970 0
Chef de Service de la Reanimation Adulte
Centre Chirurgical Marie Lannelongue
133, avenue de la Resistance
92350, le Plessis Robinson
Country 53970 0
France
Phone 53970 0
+33 (0) 1 40 94 85 80
Fax 53970 0
Email 53970 0
[email protected]
Contact person for public queries
Name 53971 0
Prof Stephan Francois
Address 53971 0
Chef de Service de la Reanimation Adulte
Centre Chirurgical Marie Lannelongue
133, avenue de la Resistance
92350, le Plessis Robinson
Country 53971 0
France
Phone 53971 0
+33 (0) 1 40 94 85 80
Fax 53971 0
+33 (0) 1 40 94 85 86
Email 53971 0
[email protected]
Contact person for scientific queries
Name 53972 0
Prof Francois STEPHAN
Address 53972 0
Chef de Service de la Reanimation Adulte
Centre Chirurgical Marie Lannelongue
133, avenue de la Resistance
92350, le Plessis Robinson
Country 53972 0
France
Phone 53972 0
+33 (0) 1 40 94 85 80
Fax 53972 0
Email 53972 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of Reperfusion Pulmonary Edema by Extravascular Lung Water Measurements after Pulmonary Endarterectomy.2017https://dx.doi.org/10.1097/CCM.0000000000002259
N.B. These documents automatically identified may not have been verified by the study sponsor.