Pulmonary Inflammation in COVID-19 ARDS
IMPU-COVID
Pulmonary Inflammation Profiles in COVID-19 Related ARDS
1 other identifier
observational
25
1 country
1
Brief Summary
Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study. This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2020
CompletedFirst Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2021
CompletedJune 23, 2021
June 1, 2021
8 months
June 21, 2021
June 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Correlation of BALF and Blood mediators with ICU mortality
Up to 3 months
Secondary Outcomes (4)
Respiratory mechanics
Day 0 (after study inclusion) and every day up to 3 months
BALF PCR
Day 0 (performance of first BALF sample) Day 8, Day 16
BALF characteristics
Day 0 (performance of first BALF sample) Day 8, Day 16
BALF cytoquines
Day 0 (performance of first BALF sample) Day 8, Day 16
Other Outcomes (2)
Hospital Mortality
Up to 3 months
Health related quality of life via SF-36 questionnaire
Up to 3 months
Interventions
Low volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis
Eligibility Criteria
COVID-19 ARDS ICU patients
You may qualify if:
- Age \> 18 years old
- COVID-19 related ARDS
- Hospitalized in ICU
- Invasive mechanical ventilation
You may not qualify if:
- Immunocompromised for previous condition
- transplanted patients
- Known pulmonary bacterial co-infection at the time of admission to the ICU
- Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F \< 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Ramon y Cajal
Madrid, 28020, Spain
Biospecimen
Bronchoalveolar Lavage Fluid samples Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 21, 2021
First Posted
June 23, 2021
Study Start
December 12, 2020
Primary Completion
August 15, 2021
Study Completion
August 16, 2021
Last Updated
June 23, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share