Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients (IGNITE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness; Respiratory Failure; Renal Failure; Acute Respiratory Distress Syndrome; Pulmonary Disease; Extracorporeal Membrane Oxygenation Complication; Cardiac Failure
• Intervention / Treatment: Device: Ventilator

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037-7381
      • University of California San Diego Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Robert L Owens, MD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; ARDS; ECMO; Biomarkers; Ventilator induced Lung Injury; Pulmonary Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Heart Failure; Respiratory Insufficiency; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 191464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Reasonable requests for IPD will be considered by the investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No