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Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19) (PiCCOVID)

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ClinicalTrials.gov Identifier: NCT04376905
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.

Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:

  1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.
  2. Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.

Condition or disease
COVID-19 Pneumonia Acute Respiratory Distress Syndrome

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Extra Vascular Lung Water and Pulmonary Permeability by Transpulmonary Thermodilution in Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 30, 2020





Primary Outcome Measures :
  1. Changes of Extra Vascular Lung Water [ Time Frame: Since intubation at day 0 and measured repetitively by 6 hours until day 3 ]
    EVLW (ml/kg) measured by a PiCCO device using TPTD thermodilution


Secondary Outcome Measures :
  1. Changes of Pulmonary Vascular Permeability Index [ Time Frame: Since intubation at day 0 and measured repetitively by 6 hours until day 3 ]
    PVPI measured by a PiCCO device using TPTDventilation, duration of ICU length of stay, ICU mortality

  2. Changes of pulmonary compliance [ Time Frame: Since intubation at day 0 and measured repetitively by 6 hours until day 3 ]
    Changes of pulmonary compliance (ml/mmHg)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 critically ill patients
Criteria

Inclusion criteria:

  • COVID-19 critically ill patients
  • Invasive mechanical ventilation

Exclusion criteria:

  • Age under 18
  • Pregnancy
  • Legally protected adults
  • Contra-indication of using PiCCO device: jugular venous thrombosis, or severe chronic femoral/iliac artery occlusive disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376905


Contacts
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Contact: Kada KLOUCHE, MD PhD +33467338441 k-klouche@chu-montpellier.fr
Contact: Fanny Garnier, chef de clinique 0601311560 ext 33 f-garnier@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Kada KLOUCHE, MD PhD    467338441 ext 33    k-klouche@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Kada KLOUCHE, MD PhD UH Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04376905    
Other Study ID Numbers: RECHMPL20_0193
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
ARDS
ICU
Transpulmonary thermodilution
Extravascular lung water
Pulmonary Vascular Permeability Index
Additional relevant MeSH terms:
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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury