Status:
COMPLETED
CACOLAC : Citrulline Administration in the Hospital Patient in Intensive Care for COVID-19 Acute Respiratory Distress Syndrome
Lead Sponsor:
Rennes University Hospital
Conditions:
ARDS Secondary to COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Respiratory involvement of SARS-CoV2 leads to acute respiratory distress syndrome (ARDS) and significant immunosuppression (lymphopenia) exposing patients to long ventilation duration and late mortali...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years;
- Patients admitted for less than 48 hours in intensive care for ARDS under mechanical ventilation according to the Berlin criteria published in 2012 (JAMA);
- Origin of ARDS: COVID-19 pneumopathy confirmed by PCR (nasopharyngeal or tracheal sample);
- Life expectancy\> 2 days;
- Affiliated to a social security scheme;
- Consent signed by the patient, the relative or the legal representative (except emergency procedure).
Exclusion
- Pregnancy or breastfeeding in progress;
- State of immunosuppression defined by at least one of these criteria: continuous administration of steroids at any dose for more than a month before hospitalization, steroids in high doses (\> 15 mg / kg / day of methylprednisolone or equivalent), radiotherapy or chemotherapy in the previous year, proven humoral or cellular deficiency;
- Contraindication to enteral nutrition (2016 SRLF recommendations: "Enteral nutrition probably should not be used upstream of a high-flow digestive fistula in the event of intestinal obstruction, small ischemia or digestive hemorrhage active (Strong chord) ").
- Ongoing immunosuppressive therapy such as chemotherapy, cyclophosphamide, high dose corticosteroid therapy (\> 15 mg / kg / day);
- Participation in intervention research on a drug, or intervention research that may impact the immune system.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04404426
Start Date
November 4 2020
End Date
May 28 2021
Last Update
June 2 2021
Active Locations (1)
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1
Rennes University Hospital
Rennes, Britanny, France, 35000