Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04719182
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-01-18
Brief Title:
Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Practice of Adjunctive Treatments in Intensive Care Unit Patients With Coronavirus Disease 2019 PRoAcT-COVID - an Observational Study in the Netherlands
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRoAcT-COVID
Brief Summary:
Rationale Many patients with coronavirus disease COVID-19 need hospital admission for oxygen supplementation A substantial number of patients need intensive care unit ICU admission for escalation of care ICU doctors and nurses are struggling to provide the best care for patients with COVID-19 Practice of adjunctive and supportive treatments remains uncertain
Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands and to determine their independent associations with outcome
Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19
Study design Nationalinternational multicenter retrospective observational study Study population Intensive care unit ICU patients with COVID-19
Methods In this study we will collect data on diverse treatments during the first 28 days in ICU including a the types of oxygen support and awake prone positioning b the types of ventilatory support c rescue therapies for refractory hypoxemia during invasive ventilation prone positioning ventilator adjustments continuous muscle paralysis and extracorporeal membrane oxygenation d adjunctive treatments including thromboprophylaxis and anticoagulation antiviral and immunomodulating therapies and e experimental supportive treatments Outcomes include duration of each adjunctive treatment duration of ventilation incidence of tracheostomy duration of stay in ICU and mortality until day 90
Study endpoints A combination of adjunctive treatments including types of oxygen support ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation primary other adjunctive and supportive treatments tracheostomy rate duration of ventilation and ventilator-free days and alive at day 28 VFD-28 duration of ICU and hospital stay and ICU hospital and 90-day mortality
Nature and extent of the burden and risks associated with participation benefit and group relatedness Retrospective collection of data regarding adjunctive treatments and clinical endpoints is without risk for ICU patients
In a subset of patients we will collect granular data every two hours regarding oxygenation FiO2 inspiratory tidal volume air flow respiratory rate SpO2 PaO2 and PEEP over the first 2 full calendar days of ICU admission The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study and one additional ICU in Spain is uploaded in the document section filename Statistical Analysis Plan PROXY-COVID
Objective To determine and compare practice of adjunctive and supportive treatments for COVID-19 in the Netherlands and to determine their independent associations with outcome
Hypotheses Practice of adjunctive and supportive treatments for COVID-19 varies substantially Adjunctive and supportive treatments have an independent association with outcome in ICU patients with COVID-19
Study design Nationalinternational multicenter retrospective observational study Study population Intensive care unit ICU patients with COVID-19
Methods In this study we will collect data on diverse treatments during the first 28 days in ICU including a the types of oxygen support and awake prone positioning b the types of ventilatory support c rescue therapies for refractory hypoxemia during invasive ventilation prone positioning ventilator adjustments continuous muscle paralysis and extracorporeal membrane oxygenation d adjunctive treatments including thromboprophylaxis and anticoagulation antiviral and immunomodulating therapies and e experimental supportive treatments Outcomes include duration of each adjunctive treatment duration of ventilation incidence of tracheostomy duration of stay in ICU and mortality until day 90
Study endpoints A combination of adjunctive treatments including types of oxygen support ventilatory support and rescue therapies for refractory hypoxemia during invasive ventilation primary other adjunctive and supportive treatments tracheostomy rate duration of ventilation and ventilator-free days and alive at day 28 VFD-28 duration of ICU and hospital stay and ICU hospital and 90-day mortality
Nature and extent of the burden and risks associated with participation benefit and group relatedness Retrospective collection of data regarding adjunctive treatments and clinical endpoints is without risk for ICU patients
In a subset of patients we will collect granular data every two hours regarding oxygenation FiO2 inspiratory tidal volume air flow respiratory rate SpO2 PaO2 and PEEP over the first 2 full calendar days of ICU admission The primary endpoint of this sub-analysis will be the amount of oxygen used with different respiratory support interventions The statistical analysis plan for the analysis of these data that were collected in two ICUs that participated in the national study and one additional ICU in Spain is uploaded in the document section filename Statistical Analysis Plan PROXY-COVID
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None