NCT04669444

Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome
• Cardiac Failure
• Extracorporeal Membrane Oxygenation Complication
• Respiratory Failure
• Renal Failure
• Critical Illness
• Pulmonary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-14
• Primary completion: 2022-03-01
• Completion: 2023-03-01
• First posted: 2020-12-16
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States