Ignite Creation Date:
2024-05-05 @ 10:57 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01228110
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2010-10-25
Brief Title:
Corticosteroids in Community Acquired Pneumonea
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents the development of sepsis related complications with a significant reduction in duration of mechanical ventilation
Detailed Description:
Inclusion Criteria Minor criteria includes
respiratory rate 30 bpm at admission
ratio of PaO2 to fraction of inspired oxygen PaO2FIO2 250
chest radiograph showing bilateral involvement or multilobar involvement
systolic blood pressure 90 mm Hg or
diastolic blood pressure 60 mm Hg Major criteria includes
Requirement of MV
Increase in the size of opacities on chest radiograph of 50 or more at 48 hours
Requirement of vasopressors for more than 4 hours or
Serum creatinine 2 mgdl or more
Exclusion criteria
Children
Nosocomial pneumonia
Hospitalisation within the previous 14 days
Severe immunosuppression chronic use of systemic steroids
Non-steroid immunosuppressive treatment or HIV
Chronic chest disease tuberculosis aspiration or obstructive pneumonia
Congestive heart failure cerebrovascular stroke
Chronic renal or hepatic disease
Acute burn injury
Malignancy
Pregnancy and
Major gastrointestinal bleed within 3 months of the current hospitalization
Study Outcome The end-points of the study were improvement in PaO2FIO2 PaO2FIO2 300 or 100 increase from study entry and sepsis related organ failure assessment SOFA score by day 8 and the development of delayed septic shock
The adopted SOFA score up to 6 points was proposed by Vincent et al 21 The number of MV-free days was defined as the number of days after ventilation was discontinued up to study day 8 Shock was defined as requirement of vasopressors ARDS was defined by consensus criteria
All the patients were subjected to
1 Routine laboratory screen including CBC RBS serum urea and creatinine liver enzymes serum billirubin and coagulation profiles
2 Chest X ray on at least on admission and at day 8
3 ABG at least once daily to detect PaO2FIO2
4 CRP daily from day 1 to 8 and
5 Evaluation of SOFA score daily
respiratory rate 30 bpm at admission
ratio of PaO2 to fraction of inspired oxygen PaO2FIO2 250
chest radiograph showing bilateral involvement or multilobar involvement
systolic blood pressure 90 mm Hg or
diastolic blood pressure 60 mm Hg Major criteria includes
Requirement of MV
Increase in the size of opacities on chest radiograph of 50 or more at 48 hours
Requirement of vasopressors for more than 4 hours or
Serum creatinine 2 mgdl or more
Exclusion criteria
Children
Nosocomial pneumonia
Hospitalisation within the previous 14 days
Severe immunosuppression chronic use of systemic steroids
Non-steroid immunosuppressive treatment or HIV
Chronic chest disease tuberculosis aspiration or obstructive pneumonia
Congestive heart failure cerebrovascular stroke
Chronic renal or hepatic disease
Acute burn injury
Malignancy
Pregnancy and
Major gastrointestinal bleed within 3 months of the current hospitalization
Study Outcome The end-points of the study were improvement in PaO2FIO2 PaO2FIO2 300 or 100 increase from study entry and sepsis related organ failure assessment SOFA score by day 8 and the development of delayed septic shock
The adopted SOFA score up to 6 points was proposed by Vincent et al 21 The number of MV-free days was defined as the number of days after ventilation was discontinued up to study day 8 Shock was defined as requirement of vasopressors ARDS was defined by consensus criteria
All the patients were subjected to
1 Routine laboratory screen including CBC RBS serum urea and creatinine liver enzymes serum billirubin and coagulation profiles
2 Chest X ray on at least on admission and at day 8
3 ABG at least once daily to detect PaO2FIO2
4 CRP daily from day 1 to 8 and
5 Evaluation of SOFA score daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None