The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
The following parameters will be recorded: Demographic data: including age, sex, smoking history. Clinical data: Glasgow coma scales, Co-morbidities are determined by reviewing the patients' clinical histories, chest examination. Vital signs: including body temperature, respiratory rate, heart rate, and arterial blood pressure. Oxygenation data: including arterial blood gases in fixed days (at the start, 3rd day and 7th day of steroid administration), ratio of partial oxygen tension in arterial blood to fraction of inspired oxygen (PaO2/FiO2 ratio). Laboratory data include complete blood picture focusing on leukocytic count and platelets, kidney and liver function tests, serum electrolytes, Erythrocyte sedimentation rate, C reactive protein, sputum culture and cortisol level before steroid administration. Radiology data include chest X-ray and chest ultrasonography at the day of diagnosis and at 7th day of steroid administration. Chest CT will be done if possible. 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.

Official Title
-----------------
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia

Conditions
-----------------
Pneumonia Hospital Acquired

Intervention / Treatment
-----------------
* Drug: Prednisone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Patients having lung cancer and those who hadn't the full data for scoring fulfilled. Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents). Condition requiring prolonged steroid use > 0.5 mg/kg/day of prednisone equivalent. Major gastrointestinal bleeding within 3 months. Patients with prolonged intubation and having tracheostomy. Patients with neurological disorders or encephalopathy. Patients with pandemic H1N1 influenza A pneumonia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisone<br>prednisone 40 mg/day for 7 days | Drug: Prednisone<br>* prednisone 40 mg/day for 7 days<br>* Other names: hostacortin;Drug: placebo<br>* 5ml saline / day for 7 days<br>|
| Experimental: placebo<br>5ml saline /day for 7 days | Drug: Prednisone<br>* prednisone 40 mg/day for 7 days<br>* Other names: hostacortin;Drug: placebo<br>* 5ml saline / day for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Hospital mortality | measure the predicting 28 day mortality for all included cases. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |