Prednisone Reduction in ICU Patients With COPD Exacerbation

NCT03981081 | Unknown Phase 4

• 1 other identifier: P01RM2019
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Copd Exacerbation Acute; Mechanical Ventilation

Keywords

COPD; Acute hypercapnic respiratory failure; Steroids

Outcome Measures

Primary Outcomes (1)

• proportion of unventilated patients at day 6

  patients breathing spontaneously by the 6th day following inclusion

  day 6

Secondary Outcomes (3)

• Number of ICU days alive without ventilatory support within 28 days after recruitment

  up to 28 days

• intubation rate in patients initially under NIV

  up to 28 days

• hospital death

  up to 28 days

Other Outcomes (1)

• serious adverse events

  up to 28 days

Study Arms (2)

eosinophil-guided group

EXPERIMENTAL

patients will receive prednisone at a dose of 1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days, only if the eosinophil count is\> 2%

Drug: Prednisone

control group

ACTIVE COMPARATOR

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

Drug: Prednisone

Interventions

Prednisone DRUG

Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients

control group; eosinophil-guided group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known or suspected COPD, and severe acute exacerbation of COPD, corresponding to an acute episode of exacerbation, associated with a hypercapnic respiratory failure (defined by RR\> 25 cycles/min, Paco2\> 6 kPa, and ph\<7.35) requiring ICU admission for ventilatory support.

You may not qualify if:

• self-reported or physician-diagnosed asthma,
• life expectancy of less than 30 days,
• allergy to systemic corticosteroids,
• severe mental illness that could not be controlled by medication,
• severe language difficulties or the inability to provide a written informed consent,
• pneumonia or patent infection,
• systemic fungal infections, or
• patients receiving more than 10 mg of chronic systemic corticosteroids (prednisone equivalent) daily.

Sponsors & Collaborators

• Hôpital Universitaire Fattouma Bourguiba: lead

Study Sites (4)

CHU Arrazi

Marrakesh, Morocco

ACTIVE NOT RECRUITING

CHU Ibn Cina

Rabat, Morocco

ACTIVE NOT RECRUITING

CHU Tahar Sfar

Mahdia, 5100, Tunisia

RECRUITING

CHU Fattouma Bourguiba

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, ICU Head

Model Details: Prospective, multicenter, randomized, open-label, parallel groups

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: April 2, 2019
• Primary Completion: March 31, 2020
• Study Completion: April 1, 2020
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

MO (2); TU (2)