Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

NCT ID: NCT04354584

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-06

Study Completion Date

2022-01-10

Brief Summary

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The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

Detailed Description

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The mechanisms of the ARDS-like respiratory failure observed in patients with COVID-19 are currently unknown, but may be related to a distinct local immune response within the lung. In the present study, we will examine the cellular and humoral pulmonary immune response in mechanically ventilated patients admitted to the ICU with COVID-19 by examining immune cell profiles, cytokine patterns, and the complement pathway in bronchoalveolar lavage fluid, and relate it to the concomitant systemic inflammatory response. We will examine the patients on day 1-3 and 7-9 after ICU admission.

Conditions

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COVID-19 Respiratory Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18y
* Mechanical ventilation
* Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
* ARDS according to the Berlin definition

Exclusion Criteria

* Untreated malignant tachycardia or bradycardia
* Suspected or verified intracranial hypertension (ICP \> 15 mmHg)
* Unilateral lung ventilation
* Severe non-correctable coagulopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ronni R. Plovsing

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronni R Plovsing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Intensive Care, University Hospital Hvidovre, Denmark

Locations

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Dept. of Intensive Care 542, University Hospital Hvidovre

Hvidovre, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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Fahnoe U, Ronit A, Berg RMG, Jorgensen SE, Mogensen TH, Underwood AP, Scheel TKH, Bukh J, Plovsing RR. A Distinct Dexamethasone-Dependent Gene Expression Profile in the Lungs of COVID-19 Patients. J Infect Dis. 2022 Dec 13;226(12):2137-2141. doi: 10.1093/infdis/jiac218.

Reference Type DERIVED
PMID: 35639922 (View on PubMed)

Other Identifiers

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H-20023159

Identifier Type: OTHER

Identifier Source: secondary_id

R349-2020-540

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

COV2ICU-DK

Identifier Type: -

Identifier Source: org_study_id

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