Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

Critical Illness Clinical Trial

— IGNITE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04669444
• Other study ID #: 191464
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Cardiac Failure
• Critical Illness
• Extracorporeal Membrane Oxygenation Complication
• Heart Failure
• Pulmonary Disease
• Renal Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Diego Health	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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