IGNITE: Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

Sponsor

University of California, San Diego (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04669444

Collaborator

(none)

Enrollment

Location

Arm

34.5

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Cardiac Failure Extracorporeal Membrane Oxygenation Complication Respiratory Failure Renal Failure Critical Illness Pulmonary Disease	Device: Ventilator	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group, interventionSingle group, intervention

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

Actual Study Start Date :

Apr 14, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Driving Pressure Protocol The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.	Device: Ventilator 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. Other Names: Breathing Machine Invasive mechanical ventilation

Arm

Intervention/Treatment

Experimental: Low Driving Pressure Protocol

The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.

Device: Ventilator

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.

Other Names:

Breathing Machine

Invasive mechanical ventilation

Outcome Measures

Primary Outcome Measures

Change in plasma IL-6 level from baseline to low driving pressure ventilation [2 hours]
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 [2 hours]
sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.