Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

NCT ID: NCT04669444

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2023-03-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low Driving Pressure Protocol

The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.

Group Type: EXPERIMENTAL

Ventilator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Breathing Machine; Invasive mechanical ventilation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Robert L. Owens

Associate Professor, Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Owens, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego Health

La Jolla, California, United States

Countries

United States

Other Identifiers

191464

Identifier Type: -

Identifier Source: org_study_id