Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

Not Applicable

Active, not recruiting

• Conditions: Renal Failure; Respiratory Failure; Acute Respiratory Distress Syndrome; Cardiac Failure; Extracorporeal Membrane Oxygenation Complication; Critical Illness; Pulmonary Disease
• Interventions: Device: Ventilator

• Registration Number: NCT04669444
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-16
• Primary Completion: 2022-03-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Driving Pressure Protocol	Ventilator	The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California San Diego Health; 🇺🇸 La Jolla, California, United States