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Clinical Trials/NCT04669444
NCT04669444Active, not recruitingNot Applicable

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

University of California, San Diego2 sites in 1 country80 target enrollmentStarted: April 14, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
80
Locations
2
Primary Endpoint
Change in plasma IL-6 level from baseline to low driving pressure ventilation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in plasma IL-6 level from baseline to low driving pressure ventilation

Time Frame: 2 hours

IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.

Secondary Outcomes

  • Change in plasma sRAGE from baseline to low driving pressure ventilation(2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert L. Owens

Associate Professor, Medicine

University of California, San Diego

Study Sites (2)

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