Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: methylprednisolone; Device: ventilators; Drug: Methyl Prednisolonate

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

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ta'if, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ventilator associated pneumonia patients

Exclusion Criteria:

• post cardiac arrest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; . 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	Drug: methylprednisolone; received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days; Device: ventilators; all patients in both groups will be ventilated with CMV for 2 weeks
Active Comparator: Group B; group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.	Device: ventilators; all patients in both groups will be ventilated with CMV for 2 weeks; Drug: Methyl Prednisolonate; received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients weaned from the ventilators	followed by arterial oxygen saturation	2 weeks
Number of patients discharge from ICU	number of patients weaned and ready to be discharged from ICU	2 weeks

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: ICU-11-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: medical doctors and intensivist

Drug and device information, study documents

• 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