Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000070538
Ethics application status
Approved
Date submitted
16/12/2023
Date registered
29/01/2024
Date last updated
29/01/2024
Date data sharing statement initially provided
29/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Carbon dioxide removal with PrismaLung in patients with respiratory failure in intensive care unit.
Scientific title
Measuring the impact of extracorporeal carbon dioxide removal using PrismaLung on ventilator induced lung injury in mechanically ventilated patients
Secondary ID [1] 311198 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory failure 332376 0
Condition category
Condition code
Respiratory 329088 329088 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No specific exposure intervention that will be evaluated in this study. It investigates how effective is the intervention (ECCO2R with PrismaLung) that is being used on the patient in reducing the lung injury known to associated with mechanical ventilation.
This study includes patients already receiving ECCO2R with PrismaLung as part of their standard mechanical ventilation treatment,
Driving pressures on the ventilator prior to initiation of PrismaLung will be compared with the driving pressures while the patients are receiving PrismaLung for up to 144 hours.
Arterial blood gasses and cytokine profile will be compared prior to initiation and after initiation of PrismaLung for up to 144 hours. All data will be available from the medical records.
Intervention code [1] 327650 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336905 0
Changes in driving airway pressures at 72 and 144 hours post initiation of ECCO2R
Timepoint [1] 336905 0
72 and 144 hours post initiation of ECCO2R
Secondary outcome [1] 430117 0
Changes in pulmonary (Lung) inflammation by assessing the interleukins in bronchial fluid
Timepoint [1] 430117 0
at 72 and 144 hours of initiation of PrismaLung
Secondary outcome [2] 430579 0
Changes in pulmonary (Lung) inflammation by assessing the interleukins in blood samples
Timepoint [2] 430579 0
at 72 and 144 hours of initiation of PrismaLung

Eligibility
Key inclusion criteria
1. Adult patients (18 years or older) with diagnosis of ARDS as per the Berlin Definition.(Ref Acute Respiratory Distress Syndrome: The Berlin Definition. JAMA. 2012; 307: 2526-33.)
2. Driving pressure ( P) > 14 and/or Plateau >/= 25 (P is calculated using as plateau pressure minus positive end-expiratory pressure). (Ref: Combes A, Auzinger G, Capellier G, et al. ECCO2R therapy in the ICU: consensus of a European round table meeting. Critical Care. 2020; 24: 490)
3. Respiratory rate > 20 breaths per minute
4. pH < 7.25 and PaCO2 >45
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ARDS lasting more than 72 hours at the time of inclusion
2. High pressure (Plateau pressure >30 cm H2O) or high FiO2 (>0·8) ventilation for more than 168 h (7 days);
3. Severe hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment
4 Contraindication to limited anticoagulation
5. Treatment limitation including not for resuscitation and not for reintubation
6. Patients with potentially irreversible respiratory failure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be presented as mean and SD of the mean or median and interquartile (25th and 75th percentile) range as appropriate. The primary outcome driving airway pressures will be analysed using linear mixed effects models (PROC MIXED procedure in SAS) fitting main effect for time (24, 48, 72 and 144 hours) with results reported as means and 95% confidence intervals (95% CI). To facilitate specific comparisons time will be treated as a categorical variable. Post-hoc comparisons will be performed to assess changes between time points. All calculated p values will be two tailed and a p < 0.05 will be considered to be statistically significant. Analyses will be performed with SAS software version 9.4 (SAS Institute, Cary, NC, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25950 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 41784 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 315460 0
Commercial sector/Industry
Name [1] 315460 0
BAXTER
Country [1] 315460 0
United States of America
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Hastings road, Frankston,VIC,3199, Australia
Country
Australia
Secondary sponsor category [1] 317529 0
None
Name [1] 317529 0
Address [1] 317529 0
Country [1] 317529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314368 0
Peninsula Health Human Research Ethics Committe
Ethics committee address [1] 314368 0
Ethics committee country [1] 314368 0
Australia
Date submitted for ethics approval [1] 314368 0
24/03/2022
Approval date [1] 314368 0
27/06/2022
Ethics approval number [1] 314368 0
HREC/85711/PH-2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131330 0
Prof Ravindranath Tiruvoipati
Address 131330 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 131330 0
Australia
Phone 131330 0
+61 431279347
Fax 131330 0
Email 131330 0
Rtiruvoipati@phcn.vic.gov.au
Contact person for public queries
Name 131331 0
Ravindranath Tiruvoipati
Address 131331 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 131331 0
Australia
Phone 131331 0
+61 431279347
Fax 131331 0
Email 131331 0
Rtiruvoipati@phcn.vic.gov.au
Contact person for scientific queries
Name 131332 0
Ravindranath Tiruvoipati
Address 131332 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 131332 0
Australia
Phone 131332 0
+61 431279347
Fax 131332 0
Email 131332 0
Rtiruvoipati@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.