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Clinical Trials/NCT04669444
NCT04669444
Active, Not Recruiting
N/A

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

University of California, San Diego1 site in 1 country80 target enrollmentApril 14, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
University of California, San Diego
Enrollment
80
Locations
1
Primary Endpoint
Change in plasma IL-6 level from baseline to low driving pressure ventilation
Status
Active, Not Recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2020
End Date
March 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert L. Owens

Associate Professor, Medicine

University of California, San Diego

Eligibility Criteria

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)

Study Sites (1)

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