Patients With Respiratory Failure and ShockedPhase 1/2NCT04555798
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
A Phase 1/2 study testing Meropenem Injection and A-V ECMO in people with Patients With Respiratory Failure and Shocked, run by Mohamed Gaber Allam at 1 site in Saudi Arabia.
Trial summary
To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Respiratory Failure and Shocked
- What is being tested?
- Meropenem Injection and A-V ECMO
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2022to 1 Feb 2022
- 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
- Those who had an age between 18-65 years old
- patients ventilated for more than 10 days
- with conscious level more than 8/15 on Glasgow Coma Scale
Who cannot join
- pediatric patients below 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion
To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.
Read the detailed description
100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had >2 SOFA score and >6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS \&VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.
- Being tested
- Meropenem Injection, A-V ECMO
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem InjectionDrug
patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
A-V ECMODevice
Only patients of group B connected to A-V ECMO for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage Receives: Drug: Meropenem Injection |
| Group B | Active comparator | group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery Receives: Drug: Meropenem Injection; Device: A-V ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients weaned from ventilators
who showed improvement in CPIS score
Measured: 2 weeks
number of patients disharged from ICU
who successfully weaned from the ventilator and complete 24 hours observation without symptoms
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 posted21 Sep 2020
- Study start1 Feb 2022
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Respiratory Failure and ShockedStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 100 patients from those who showed no improvement after 10 days ventilation and still had respiratory failure and in need of high ventilatory parameters (as mentioned before), fulfilled \> 2 parameters on SOFA score as illustrated in table (2), \> 6 on CPIS score as illustrated in table (3) and developed circulatory failure (septic shock) with nor-adrenaline infusion and only on high dose of nor-adrenaline included in our study (\>5microgram/kg/minute intravenous infusion as circulatory support). Since the parameters of those 100 patients selected are considered indication for arteriovenous extracorporeal membranous (A-V ECMO), so patients randomly allocated in two groups 50 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Gaber Allam
- Sponsor type
- Research network
- Collaborators
- King Abdul Aziz Specialist Hospital
- Responsible party
- Sponsor-investigator, Mohamed Gaber Allam, King Abdul Aziz Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555798
- Sponsor's protocol ID
- ICU-44-20
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: only after publishing the work in specific journal
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion
- ClinicalTrials.gov ID
- NCT04555798
- Acronym / sponsor ID
- ICU-44-20
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohamed Gaber AllamResearch network
- Collaborators
- King Abdul Aziz Specialist Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 21 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 and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.
Detailed description
100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had >2 SOFA score and >6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS \&VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 100 patients from those who showed no improvement after 10 days ventilation and still had respiratory failure and in need of high ventilatory parameters (as mentioned before), fulfilled > 2 parameters on SOFA score as illustrated in table (2), > 6 on CPIS score as illustrated in table (3) and developed circulatory failure (septic shock) with nor-adrenaline infusion and only on high dose of nor-adrenaline included in our study (>5microgram/kg/minute intravenous infusion as circulatory support). Since the parameters of those 100 patients selected are considered indication for arteriovenous extracorporeal membranous (A-V ECMO), so patients randomly allocated in two groups 50 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Meropenem InjectionGroup A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage |
| Group B | Active comparator | Drug: Meropenem Injection, Device: A-V ECMOgroup B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who had an age between 18-65 years old
- patients ventilated for more than 10 days
- with conscious level more than 8/15 on Glasgow Coma Scale
Key exclusion criteria (1 listed)
- pediatric patients below 18 years of age
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 |
|---|---|---|
| Meropenem Injectionpatients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture | Drug | Group A, Group B |
| A-V ECMOOnly patients of group B connected to A-V ECMO for two weeks | Device | Group B |
Primary outcome
number of patients weaned from ventilators
Time frame: 2 weeks
who showed improvement in CPIS score
number of patients disharged from ICU
Time frame: 2 weeks
who successfully weaned from the ventilator and complete 24 hours observation without symptoms
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 12 Apr 2022.
- Individual participant dataSharing planned: No. only after publishing the work in specific journal
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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 Injection and A-V ECMO in people with Patients With Respiratory Failure and Shocked, run by Mohamed Gaber Allam 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 3 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 12 Apr 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 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 12 Apr 2022.