Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
methylprednisolone
Methyl Prednisolonate
ventilators
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Associated Pneumonia
Eligibility Criteria
Inclusion Criteria:
- ventilator associated pneumonia patients
Exclusion Criteria:
- post cardiac arrest
Sites / Locations
- King abd el Aziz specialist hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
. Group A 120 patients, received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
Outcomes
Primary Outcome Measures
Number of patients weaned from the ventilators
followed by arterial oxygen saturation
Number of patients discharge from ICU
number of patients weaned and ready to be discharged from ICU
Secondary Outcome Measures
Full Information
NCT ID
NCT04467892
First Posted
June 6, 2020
Last Updated
July 8, 2020
Sponsor
King Abdul Aziz Specialist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04467892
Brief Title
Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
Official Title
Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdul Aziz Specialist Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
patients who had >3 on Murray score and >6 on CPIS allocated randomly in two groups 120 patients in each. Group A received 30 mg/kg methyl-prednisolone slowly intravenous in 250 mL normal saline every 8 hours for only 48 hours while group B received 1 mg/kg/day methyl-prednisolone divided to three doses given every 8 hours for two weeks. Duration of the study last 16 days, Morbidity considered if no improvement in any or all clinical parameters of both Murray and CPIS scores and failure of weaning of patients from the ventilator at the studied period.
Detailed Description
Adult patients aged >18<65 years, hypercapnia with PH <7.25, hypoxic index less than 200 (PaO2/FIO2), bilateral parenchymatous lung infiltration in the chest Xray. All selected patients received conventional ventilation with protective lung strategy for 3 days with Controlled mechanical ventilation mode (CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure (PEEP) adjusted to achieve target arterial oxygen saturation (SPO2) of >90%. Sedation and pain control done by both midazolam and fentanyl infusion to achieve Richmond Agitation- Sedation Scale (RASS) -2. Protective lung strategy applied and include, head elevation more than 45-degree, daily assessment for both analgesic and sedative dose, early naso-gastric feeding to prevent bacterial translocation and flooding of the blood with gram negative septicemia, usage of the minimal PEEP to maintain SPO2 >90%. Qualitative sputum culture was taken after 3 days from ventilation. After 3 days from the conventional ventilation only 240 patients enrolled in our study. Those who had a Murray score (for diagnosis of ARDS) of >3 and CPIS (clinical pulmonary infection score) (for diagnosis of VAP) > 6. All patients were randomly allocated in 2 groups 120 patients in each. All patients received intravenous antibiotics meropenem 1 gm slowly intravenous every 8 hours for the first 8 days then antibiotics was given according to sputum culture and antibiotics sensitivity. Group A received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days while group B included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. This study conducted for 16 days.
VAP diagnosed in our study by CPIS 6 or more while severity of lung contusion assessed by Murray score 3 or more
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients who had severe chest trauma with massive lung contusion and admitted to King Abdelaziz specialist hospital between January 2018 and February 2020 in the intensive care unit those who showed the following inclusion criteria of ARDS, respiratory failure due to severe lung contusion complicated by VAP enrolled in our study
Masking
None (Open Label)
Masking Description
patients with COPD respiratory failure, patients with congestive heart failure
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
. Group A 120 patients, received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
Intervention Type
Drug
Intervention Name(s)
Methyl Prednisolonate
Intervention Description
received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
Intervention Type
Device
Intervention Name(s)
ventilators
Intervention Description
all patients in both groups will be ventilated with CMV for 2 weeks
Primary Outcome Measure Information:
Title
Number of patients weaned from the ventilators
Description
followed by arterial oxygen saturation
Time Frame
2 weeks
Title
Number of patients discharge from ICU
Description
number of patients weaned and ready to be discharged from ICU
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ventilator associated pneumonia patients
Exclusion Criteria:
post cardiac arrest
Facility Information:
Facility Name
King abd el Aziz specialist hospital
City
Ta'if
ZIP/Postal Code
21944
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
medical doctors and intensivist
Learn more about this trial
Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
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