Acute Respiratory Distress SyndromeIGNITENCT04669444
Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
A study testing Ventilator in people with Acute Respiratory Distress Syndrome and Cardiac Failure, run by University of California, San Diego at 1 site in United States.
Trial summary
Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
- Patient that is a potential ECMO candidate.
Who cannot join
- History of Lung or Cardiac Transplantation
- Patient is not committed to full support
- Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 4-6 hours (if patient is mechanically ventilated)
- Inability to get informed consent from the patient or surrogate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Health
La Jolla, California, 92037-7381
About this study
Official title: Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.
- Conditions
- Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication, Respiratory Failure, Renal Failure, Critical Illness
- Being tested
- Ventilator
- Keywords
- ECMO, ARDS, Ventilator induced Lung Injury, Heart Failure, Pulmonary Failure, Biomarkers
- Medical subject headings
- Respiratory Distress Syndrome, Heart Failure, Respiratory Insufficiency, Renal Insufficiency, Critical Illness, Lung Diseases, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilatorDevice
Also called Breathing Machine, Invasive mechanical ventilation
The patient starts at a ventilator driving pressure of 10-15 cm of H2O as per guidelines for patients on ECMO with ARDS. The driving pressure is then decreased as tolerated for two hours to evaluate the effects on pulmonary, cardiac, and inflammatory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Low Driving Pressure Protocol | Experimental | The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support. Receives: Device: Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma IL-6 level from baseline to low driving pressure ventilation
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.
Measured: 2 hours
Secondary outcomes (1)
Change in plasma sRAGE from baseline to low driving pressure ventilation
sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start14 Apr 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, intervention
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert L Owens, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669444
- Sponsor's protocol ID
- 191464
- Acronym
- IGNITE
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests for IPD will be considered by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
- ClinicalTrials.gov ID
- NCT04669444
- Acronym / sponsor ID
- IGNITE / 191464
- Conditions
- Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication, Respiratory Failure, Renal Failure, Critical Illness
- Keywords
- ECMO, ARDS, Ventilator induced Lung Injury, Heart Failure, Pulmonary Failure, Biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 Dec 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 in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, intervention
| Arm | Type | Receives |
|---|---|---|
| Low Driving Pressure Protocol | Experimental | Device: VentilatorThe patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
- Patient that is a potential ECMO candidate.
Key exclusion criteria (4 listed)
- History of Lung or Cardiac Transplantation
- Patient is not committed to full support
- Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 4-6 hours (if patient is mechanically ventilated)
- Inability to get informed consent from the patient or surrogate.
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 |
|---|---|---|
| VentilatorAlso: Breathing Machine, Invasive mechanical ventilationThe patient starts at a ventilator driving pressure of 10-15 cm of H2O as per guidelines for patients on ECMO with ARDS. The driving pressure is then decreased as tolerated for two hours to evaluate the effects on pulmonary, cardiac, and inflammatory biomarkers. | Device | Low Driving Pressure Protocol |
Primary outcome
Change in plasma IL-6 level from baseline to low driving pressure ventilation
Time frame: 2 hours
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.
1 secondary outcome
Change in plasma sRAGE from baseline to low driving pressure ventilation
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Undecided. Reasonable requests for IPD will be considered by the investigators.
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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.
Robert L Owens, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator in people with Acute Respiratory Distress Syndrome and Cardiac Failure, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2023. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in plasma IL-6 level from baseline to low driving pressure ventilation (time frame: 2 hours). 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 26 Jan 2023.