Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients (IGNITE)
Primary Purpose
Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilator
Sponsored by
About this trial
This is an interventional basic science trial for Acute Respiratory Distress Syndrome focused on measuring ECMO, ARDS, Ventilator induced Lung Injury, Heart Failure, Pulmonary Failure, Biomarkers
Eligibility Criteria
Inclusion Criteria
- Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
- Patient that is a potential ECMO candidate.
Exclusion Criteria
- 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.
Sites / Locations
- University of California San Diego Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Driving Pressure Protocol
Arm Description
The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04669444
First Posted
December 9, 2020
Last Updated
January 25, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04669444
Brief Title
Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Acronym
IGNITE
Official Title
Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Cardiac Failure, Extracorporeal Membrane Oxygenation Complication, Respiratory Failure, Renal Failure, Critical Illness, Pulmonary Disease
Keywords
ECMO, ARDS, Ventilator induced Lung Injury, Heart Failure, Pulmonary Failure, Biomarkers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Driving Pressure Protocol
Arm Type
Experimental
Arm Description
The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.
Intervention Type
Device
Intervention Name(s)
Ventilator
Other Intervention Name(s)
Breathing Machine, Invasive mechanical ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in plasma IL-6 level from baseline to low driving pressure ventilation
Description
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change in plasma sRAGE from baseline to low driving pressure ventilation
Description
sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
Patient that is a potential ECMO candidate.
Exclusion Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Owens, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7381
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Reasonable requests for IPD will be considered by the investigators.
Learn more about this trial
Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
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