Glucocorticoids versus placebo for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a randomized controlled trial

Conditions

IDIOPATHIC PULMONARY FIBROSIS

Brief summary

Parameter: all-cause mortality rate; Timetable: Day 30.

Detailed description

vital status assessment at Day 30 and Day 90 with time (in days) between randomization and death, Overall mortality at Day 90, Death or transplantation at Day 90, Mortality linked to the respiratory disease at Day 30 and Day 90, Time (in days) from randomization to worsening, percentage of patients admitted to ICU, Percentage of patients requiring invasive ventilation, length of hospital-stay, Progression of pulmonary fibrosis, Absolute change in percent Forced Vital Capacity and DLCO, Infectious disease, Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to hospital withdraw, discharge hospital visit, Day 30, Day 90, Cardiovascular disorder ( heart rate, blood pressure, clinical history daily), Neuropsychological disturbances, Clinical laboratory evaluation (blood count, serum chemistries and creatinin measurement), Dyspnea evaluation, Hospital Anxiety and Depression Scale (HADs), 7-category ordinal scale at day 15

Related papers

No related papers found yet.

Interventions

DRUGSucrose octaacetate [NF]

DRUGSODIUM CHLORIDE

DRUGMETHYLPREDNISOLONE VIATRIS 1 g

DRUGpoudre pour solution injectable (I.V.)

DRUGLIQUID PREDNISONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Parameter: all-cause mortality rate; Timetable: Day 30.	—

Secondary

Measure	Time frame
vital status assessment at Day 30 and Day 90 with time (in days) between randomization and death, Overall mortality at Day 90, Death or transplantation at Day 90, Mortality linked to the respiratory disease at Day 30 and Day 90, Time (in days) from randomization to worsening, percentage of patients admitted to ICU, Percentage of patients requiring invasive ventilation, length of hospital-stay, Progression of pulmonary fibrosis, Absolute change in percent Forced Vital Capacity and DLCO, Infectious disease, Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to hospital withdraw, discharge hospital visit, Day 30, Day 90, Cardiovascular disorder ( heart rate, blood pressure, clinical history daily), Neuropsychological disturbances, Clinical laboratory evaluation (blood count, serum chemistries and creatinin measurement), Dyspnea evaluation, Hospital Anxiety and Depression Scale (HADs), 7-category ordinal scale at day 15	—

Measure

Time frame

vital status assessment at Day 30 and Day 90 with time (in days) between randomization and death, Overall mortality at Day 90, Death or transplantation at Day 90, Mortality linked to the respiratory disease at Day 30 and Day 90, Time (in days) from randomization to worsening, percentage of patients admitted to ICU, Percentage of patients requiring invasive ventilation, length of hospital-stay, Progression of pulmonary fibrosis, Absolute change in percent Forced Vital Capacity and DLCO, Infectious disease, Capillary blood glucose monitoring and/or fasting blood glucose daily from D1 to hospital withdraw, discharge hospital visit, Day 30, Day 90, Cardiovascular disorder ( heart rate, blood pressure, clinical history daily), Neuropsychological disturbances, Clinical laboratory evaluation (blood count, serum chemistries and creatinin measurement), Dyspnea evaluation, Hospital Anxiety and Depression Scale (HADs), 7-category ordinal scale at day 15

—

Countries

France

Outcome results

None listed