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

Sponsor
Assiut University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03121690
Collaborator
(none)
500
1
2
36
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Actual Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: prednisone

prednisone 40 mg/day for 7 days

Drug: Prednisone
prednisone 40 mg/day for 7 days
Other Names:
  • hostacortin
  • Drug: placebo
    5ml saline / day for 7 days

    Experimental: placebo

    5ml saline /day for 7 days

    Drug: Prednisone
    prednisone 40 mg/day for 7 days
    Other Names:
  • hostacortin
  • Drug: placebo
    5ml saline / day for 7 days

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Hospital mortality [28 days]

      measure the predicting 28 day mortality for all included cases.

    Secondary Outcome Measures

    1. Percentage of ICU needing [28 days]

      the need of non-invasive ventilation and mechanical ventilation

    2. Time to clinical stability [28 days]

      measure time to resolution of vital signs, ability to eat and mental status

    3. complications of hospitalization [28 days]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rabab Hamed Hassan Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hassan Abd-Elatif bayoumi, lecturer, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rabab Hamed Hassan, specialist of chest and tuberculosis, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03121690
    Other Study ID Numbers:
    • 17200051
    First Posted:
    Apr 20, 2017
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 13, 2020