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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04433325
Other study ID # 35RC20_3091_TOCCIP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2020
Est. completion date September 2020

Study information

Verified date June 2020
Source Rennes University Hospital
Contact Nicolas Mevel
Phone 0299282555
Email dri@chu-rennes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 2020
Est. primary completion date July 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and 15/04/2020

- Patients (or legal representative) with no opposition to inclusion in medical research protocol

- Regarding case group : Patients transferred from Paris's ICU

- Regarding case control group : Patients admitted in ICU with no transfer from Paris

Exclusion Criteria:

- > 18 years under legal protection and patients with liberty restriction

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Poitiers Poitiers
France CHU Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of death to evaluate mortality at Intensive Care Units discharge, an average of 1 months
Secondary number of infections to evaluate morbidity from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days of mechanical ventilation from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days of sedation from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days of use of neuromuscular blocking agents from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days of vasopressor use from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days in Intensive Care Units from date of admission until Intensive Care Units discharge, assessed up to 1 months
Secondary number of days in hospital from date of admission until hospital discharge, assessed up to 1 months
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