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Cross sectional randomized clinical trial study will be done at Respiratory intensive care unit and Chest department at Assiut University Hospitals on All patients who developed hospital acquired pneumonia including ventilator associated pneumonia through two years duration to assess the prognostic value of different severity scores including (PSI, CURB65, SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe conditions and measurement of cortisol level to assess steroid response before administration.
The following parameters will be recorded:
Procedures: Systemic steroids will be administered early with a dosages equivalent to prednisone 40 mg/day for 7 days which is considered as a "stress dose" of systemic corticosteroids for pneumonia. The patients will also receive the appropriate initial intravenous antibiotic medication and the standard care as recommended in RICU policy. Cortisol level will be measured before steroid administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prednisone | Experimental | prednisone 40 mg/day for 7 days |
|
| placebo | Experimental | 5ml saline /day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | prednisone 40 mg/day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Hospital mortality | measure the predicting 28 day mortality for all included cases. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ICU needing | the need of non-invasive ventilation and mechanical ventilation | 28 days |
| Time to clinical stability | measure time to resolution of vital signs, ability to eat and mental status |
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Inclusion Criteria:
This study will be conducted on admitted patients aged ≥18 years that developed hospital acquired pneumonia including ventilator associated pneumonia. Its diagnosis is confirmed by developing pneumonia after 48 H of admission and they had new or progressive infiltrates on the chest X-ray with one of the 3 requirements of: fever more than 37.8 C or purulent sputum or leukocytosis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Abd-Elatif bayoumi, lecturer | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabab Hamed Hassan | Asyut | Egypt |
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| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo | Drug | 5ml saline / day for 7 days |
|
| 28 days |
| complications of hospitalization | occurrence of complication arising during hospitalization (ARDS, shock, sepsis, major arrhythmia include atrial fibrillation and supraventricular tachycardia , renal failure, electrolyte disturbance, deep venous thrombosis and GIT bleeding). | 28 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |