Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia

NCT04467892 | Completed Phase 2

• 1 other identifier: ICU-11-20
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

. 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; Device: ventilators

Group B

ACTIVE COMPARATOR

group B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.

Drug: Methyl Prednisolonate; Device: ventilators

Interventions

methylprednisolone DRUG

received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days

Group A

Methyl Prednisolonate DRUG

received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.

Group B

ventilators DEVICE

all patients in both groups will be ventilated with CMV for 2 weeks

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ventilator associated pneumonia patients

You may not qualify if:

• post cardiac arrest

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Methylprednisolone; methyl prednisolonate; Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: patients with COPD respiratory failure, patients with congestive heart failure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: July 13, 2020
• Study Start: January 2, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 25, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)