Clinical trial NCT03121690: The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Official title: The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumonia Hospital Acquired
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Percentage of Hospital mortality
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of ICU needing
timeFrame: 28 days
measure: Time to clinical stability
timeFrame: 28 days
measure: complications of hospitalization
timeFrame: 28 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Rabab Hamed Hassan
Study officials:
affiliation: Assiut University
name: Hassan Abd-Elatif bayoumi, lecturer
role: PRINCIPAL_INVESTIGATOR
References: