Prednisone Reduction in ICU Patients With COPD Exacerbation
Status:
Unknown status
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
Summary
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label,
non-inferiority study is to evaluate a prednisone prescribing strategy, guided by eosinophil
blood count compared to the standard (systematic) administration of corticosteroids, in
patients with COPD exacerbation requiring ventilatory support.
Patients fulfilling inclusion criteria and consenting to participate in the study, will be
randomized through a random table generated electronically, to eosinophil-guided group or to
control group.
In the eosinophil-guided group, prednisone (1mg/kg/day for up to 5 days or during the
hospital stay if less than 5 days) is administered only if the eosinophil count is >2%. If
blood eosinophil count is ≤2%, no corticosteroids are given. In the control group: a
treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a
maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid
treatment is taken in the morning in patients with NIV, and through the gastric tube in
intubated patients.
The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to
the standard strategy, with less exposure to corticosteroids.
The primary endpoint is the proportion of unventilated patients at day 6 which is set to 50%
in the control group. A pre-specified difference <10% would be a non-inferiority margin.
Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days
after recruitment, length of stay in intensive care Unit, the intubation rate in patients
initially under NIV, Mortality in the ICU, Hospital mortality.
Safety: New onset of diabetes or worsening of diabetes requiring the start or the increase in
insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion
or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new
antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate /
recurrence defined respectively by the rate of a new hospital consultation and/or admission
in the week or the month following index hospitalization.
Sample size calculation: In a non-inferiority study, with an incidence of the event (no
ventilation at D6) of 50% in the control group ( with 10% of acceptable difference for
non-inferiority), a power of 80% and alpha error <0.05, it would take 86 patients per arm by
anticipating 2% of lost sight.