The study has two objectives:1. To relate pulmonary fibroblast activity in non-resolving ARDS patients, measured by FAPI-PET/CT, to the 28 days mortality, ventilator-free days of 28 days (VFD-28) and ICU length of stay. 2. To study the relationship…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Health condition
COVID 19
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To quantify pulmonal fibroblast activity via [68Ga]-FAPI PET in non-resolving
ARDS patients in the ICU and the relation with disease specific survival,
length of stay at the ICU and ventilator free days at day 28.
Secondary outcome
To study the relationship between pulmonal [68Ga]-FAPI uptake and systemic
blood markers of inflammation and extracellular matrix remodelling.
Background summary
Of all the patients requiring mechanical ventilation at the ICU 23% fulfill
criteria meeting the Acute Respiratory Distress Syndrome (ARDS). Mortality in
this syndrome remains high with up to 30-46% in moderate and severe ARDS. The
fibroproliferative phase plays an important role in patients not recovering
from ARDS. Bronchoalveolar lavage (BAL) can be used to investigate this
process. However, quantitative assessment using BAL of fibroblast activity in
both lungs is invasive and has yielded inconsistent results, and this has
precluded clinical utility. New methods to assess fibroblast activity in ARDS
are therefore needed. A novel tool is PET/CT with the tracer [68Ga]-FAPI.
[68Ga]-FAPI PET has the ability for reproducible and non-invasive measurement
of fibroblast activity.
Study objective
The study has two objectives:
1. To relate pulmonary fibroblast activity in non-resolving ARDS patients,
measured by FAPI-PET/CT, to the 28 days mortality, ventilator-free days of 28
days (VFD-28) and ICU length of stay.
2. To study the relationship between pulmonary fibroblast activity and systemic
fibrotic and inflammatory blood markers
Study design
A single centre prospective observational study
Intervention
Not applicable
Study burden and risks
Subjects do not have direct benefits from participating in this study. However,
the risks of performing PET/CT in critical ill patients are low and the effect
of the gained knowledge could potentially be of great influence on future
diagnosis and treatment plans, hopefully eventually leading up to a higher
survival rate of those patients. The study should be performed in
critically-ill patients since ARDS patients are typically admitted to the ICU,
and the expected clinical benefits will also be within this group.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Adult (male >= 20 years of age and female >= 20 years of age) patients
• Mechanically ventilated
• Patient meets the criteria for non-resolving ARDS as at day 5 of the ARDS
diagnosis one or more of the following criteria is true:
o P/F ratio <300 mmHg
o Positive End Expiratory Pressure (PEEP) at 12 cmH2O or more
o Static lung compliance of < 50 ml/cmH2O
• Deemed safe for transport by treating clinician (staff Intensivist)
• Informed consent signed by patient or relative
In case of COVID-19 non-resolving ARDS the following criteria must be met:
• Adult (male >= 20 years of age and female >= 20 years of age) patients
• Mechanically ventilated
• Patient meets the criteria for non-resolving ARDS as SARS-CoV-2 PCR CT >30
and one or more of the following criteria is true:
o P/F ratio <300 mmHg
o Positive End Expiratory Pressure (PEEP) at 12 cmH2O or more
o Static lung compliance of < 50 ml/cmH2O
• Deemed safe for transport by treating clinician (staff Intensivist)
• Informed consent signed by patient or relative
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Women who are pregnant or breastfeeding
• Inability to attain informed consent
• Too unstable for transport as judged by the treating staff intensivist
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-003701-29-NL |
| CCMO | NL83114.042.22 |