ARDSPhase 1/2NCT04553367
Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
A Phase 1/2 study testing Meropenem, bronchoscopy and ventilator in people with ARDS and Septic Shock, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ARDS, Septic Shock
- What is being tested?
- Meropenem, bronchoscopy and ventilator
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Jul 2020to 1 Dec 2021
- Phase
- Phase 1/2
- 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
- patients with age group between 18-65 years,patients Respiratory failure, patients with pneumonia
Who cannot join
- pediatric patients, patients with anoxic brain insult
Trial locations and contacts
1 site in 1 country.
About this study
to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.
Read the detailed description
age group between 18-65 years, intubated and ventilated patients due to respiratory failure from severe lung infection and/or traumatic lung contusion [respiratory failure was diagnosed by arterial blood gases (ABG) with partial pressure of oxygen (PaO2) ≤60 mmHg, partial pressure of carbon dioxide (PaCO2)≥60 mmHg, PH > 7.30, respiratory rate >25 min]. All patients ventilated for 4 days with CMV with respiratory rate 12/min, PEEP 5 cm/H2O, FIO2 adjusted to maintain arterial oxygen saturation above 90%. And sedated with both fentanyl and midazolam intravenous infusion to adjust sedation level to achieve Richmond Agitation-Sedation Scale (RASS) -2 to -3 as illustrated in table. All patients received broad spectrum antibiotics in form of meropenem 1 gm slowly intravenous every 8 hours in this period (four days) and a qualitative sputum culture collected from all patients after 3 days from ventilation. Feeding started on the second day of ventilation to all patients through feeding pump at rate of 70 ml insure plus (Abbot company) with 1.47 kilo-calorie/ml to supply patients with approximately 2500 kilo-calorie in 24 hours calculated by approximately 35 kilo-calorie/kg. The 5 points of bundle for pneumonia prevention were strictly applied to all patients: Elevation of the head of the bed 30º to 45º, Daily evaluation for possible ex-tubation, The use of endotracheal tube with subglottic secretion drainage, oral care with oral antiseptics, initiation of safe enteral nutrition, within 24-48 hours from ICU admission and ventilation.
200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled > 2 parameters on SOFA score and > 6 on pneumonia score and randomly allocated in two groups 100 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time.
All patients selected underwent a percutaneous tracheostomy on the same day. Sepsis documented in our study by > 2 on Sequential Organ Failure Assessment (SOFA) score. While VAP documented in our study by >6 on CPIS score. Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl infusion to get same sedation score mentioned before (RASS-2/-3), increase FIO2 to 100% during the procedure, use xylocaine spray 10% by Astra Zeneca company 2 puffs in each nostril before application of the rubber tube of the bronchoscope, keep patient's head elevated 20 degree during procedure, use CMV mode with previous mentioned parameters with 100% FIO2 during the procedure, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture and the other isotonic saline injected in the remaining three syringe used only for wash the small airways and not for bacteriological sampling, monitoring of patients during the procedure done by SPO2, non-invasive blood pressure measurement every 5 minutes, electro cardiac gram for heart rate, clinical assessment of depth of sedation every 5 minutes.
Duration of the study selected to be 2 weeks and evaluation of all patients in both groups done on three periods, at the end of the first 5 days, at the end of the second 5 days and at the end of last 4 days.
- Conditions
- ARDS, Septic Shock
- Being tested
- Meropenem, bronchoscopy, ventilator
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
all patients in both groups receive meropenam and put on the ventilators for 2 weeks
bronchoscopyProcedure or surgery
Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period
ventilatorDevice
ventilator
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | patients of group A Continue on the conventional way of ventilation and . Microbiological results collected from patients of group A through qualitative sputum. Receives: Drug: Meropenem; Device: ventilator |
| Group B | Active comparator | had three times bronchoscopy one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture Receives: Drug: Meropenem; Procedure: bronchoscopy; Device: ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients weaned from the ventilator
those who had improvement in all parameters of sepsis (SOFA score) and improvement in (CPIS) score
Measured: 2 weeks
number of patients disharged from ICU
Those who weaned from the ventilator and recoverd from sepsis
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 posted17 Sep 2020
- Study start2 Jul 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled \> 2 parameters on SOFA score \[9-10\] and \> 6 on CPIS score and randomly allocated in two groups 100 patients in each.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 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
- NCT04553367
- Sponsor's protocol ID
- ICU-40-20
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation
- ClinicalTrials.gov ID
- NCT04553367
- Acronym / sponsor ID
- ICU-40-20
- Conditions
- ARDS, Septic Shock
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Abdul Aziz Specialist HospitalResearch network
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 17 Sep 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.
to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.
Detailed description
age group between 18-65 years, intubated and ventilated patients due to respiratory failure from severe lung infection and/or traumatic lung contusion [respiratory failure was diagnosed by arterial blood gases (ABG) with partial pressure of oxygen (PaO2) ≤60 mmHg, partial pressure of carbon dioxide (PaCO2)≥60 mmHg, PH > 7.30, respiratory rate >25 min]. All patients ventilated for 4 days with CMV with respiratory rate 12/min, PEEP 5 cm/H2O, FIO2 adjusted to maintain arterial oxygen saturation above 90%. And sedated with both fentanyl and midazolam intravenous infusion to adjust sedation level to achieve Richmond Agitation-Sedation Scale (RASS) -2 to -3 as illustrated in table. All patients received broad spectrum antibiotics in form of meropenem 1 gm slowly intravenous every 8 hours in this period (four days) and a qualitative sputum culture collected from all patients after 3 days from ventilation. Feeding started on the second day of ventilation to all patients through feeding pump at rate of 70 ml insure plus (Abbot company) with 1.47 kilo-calorie/ml to supply patients with approximately 2500 kilo-calorie in 24 hours calculated by approximately 35 kilo-calorie/kg. The 5 points of bundle for pneumonia prevention were strictly applied to all patients: Elevation of the head of the bed 30º to 45º, Daily evaluation for possible ex-tubation, The use of endotracheal tube with subglottic secretion drainage, oral care with oral antiseptics, initiation of safe enteral nutrition, within 24-48 hours from ICU admission and ventilation.
200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled > 2 parameters on SOFA score and > 6 on pneumonia score and randomly allocated in two groups 100 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time.
All patients selected underwent a percutaneous tracheostomy on the same day. Sepsis documented in our study by > 2 on Sequential Organ Failure Assessment (SOFA) score. While VAP documented in our study by >6 on CPIS score. Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl infusion to get same sedation score mentioned before (RASS-2/-3), increase FIO2 to 100% during the procedure, use xylocaine spray 10% by Astra Zeneca company 2 puffs in each nostril before application of the rubber tube of the bronchoscope, keep patient's head elevated 20 degree during procedure, use CMV mode with previous mentioned parameters with 100% FIO2 during the procedure, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture and the other isotonic saline injected in the remaining three syringe used only for wash the small airways and not for bacteriological sampling, monitoring of patients during the procedure done by SPO2, non-invasive blood pressure measurement every 5 minutes, electro cardiac gram for heart rate, clinical assessment of depth of sedation every 5 minutes.
Duration of the study selected to be 2 weeks and evaluation of all patients in both groups done on three periods, at the end of the first 5 days, at the end of the second 5 days and at the end of last 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled > 2 parameters on SOFA score [9-10] and > 6 on CPIS score and randomly allocated in two groups 100 patients in each.
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Meropenem, Device: ventilatorpatients of group A Continue on the conventional way of ventilation and . Microbiological results collected from patients of group A through qualitative sputum. |
| Group B | Active comparator | Drug: Meropenem, Procedure: bronchoscopy, Device: ventilatorhad three times bronchoscopy one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with age group between 18-65 years,patients Respiratory failure, patients with pneumonia
Key exclusion criteria (1 listed)
- pediatric patients, patients with anoxic brain insult
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 |
|---|---|---|
| Meropenemall patients in both groups receive meropenam and put on the ventilators for 2 weeks | Drug | Group A, Group B |
| bronchoscopyOnly patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period | Procedure or surgery | Group B |
| ventilatorventilator | Device | Group A, Group B |
Primary outcome
number of patients weaned from the ventilator
Time frame: 2 weeks
those who had improvement in all parameters of sepsis (SOFA score) and improvement in (CPIS) score
number of patients disharged from ICU
Time frame: 2 weeks
Those who weaned from the ventilator and recoverd from sepsis
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 6 Jul 2022.
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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 1/2 study testing Meropenem, bronchoscopy and ventilator in people with ARDS and Septic Shock, 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 6 Jul 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 ventilator (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 6 Jul 2022.