Ventilator Associated PneumoniaPhase 2NCT04467892
Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
A Phase 2 study testing methylprednisolone, Methyl Prednisolonate and ventilators in people with Ventilator Associated Pneumonia, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- methylprednisolone, Methyl Prednisolonate and ventilators
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Jan 2018to 25 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ventilator associated pneumonia patients
Who cannot join
- post cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- methylprednisolone, Methyl Prednisolonate, ventilators
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
Methyl PrednisolonateDrug
received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
ventilatorsDevice
all patients in both groups will be ventilated with CMV for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Methyl Prednisolonate; Device: ventilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients weaned from the ventilators
followed by arterial oxygen saturation
Measured: 2 weeks
Number of patients discharge from ICU
number of patients weaned and ready to be discharged from ICU
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start2 Jan 2018
- Primary completion14 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdul Aziz Specialist Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467892
- Sponsor's protocol ID
- ICU-11-20
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: medical doctors and intensivist
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04467892
- Acronym / sponsor ID
- ICU-11-20
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- King Abdul Aziz Specialist HospitalResearch network
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: methylprednisolone, Device: ventilators. 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 | Active comparator | Drug: Methyl Prednisolonate, Device: ventilatorsgroup B 120 patients, included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ventilator associated pneumonia patients
Key exclusion criteria (1 listed)
- post cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisolonereceived high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days | Drug | Group A |
| Methyl Prednisolonatereceived 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. | Drug | Group B |
| ventilatorsall patients in both groups will be ventilated with CMV for 2 weeks | Device | Group A, Group B |
Primary outcome
Number of patients weaned from the ventilators
Time frame: 2 weeks
followed by arterial oxygen saturation
Number of patients discharge from ICU
Time frame: 2 weeks
number of patients weaned and ready to be discharged from ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No. medical doctors and intensivist
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylprednisolone, Methyl Prednisolonate and ventilators in people with Ventilator Associated Pneumonia, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients weaned from the ventilators (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.