Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

NCT04669444 | Unknown

• 1 other identifier: 191464
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

ECMO; ARDS; Ventilator induced Lung Injury; Heart Failure; Pulmonary Failure; Biomarkers

Outcome Measures

Primary Outcomes (1)

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

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

  2 hours

Secondary Outcomes (1)

• Change in plasma sRAGE from baseline to low driving pressure ventilation

  2 hours

Study Arms (1)

Low Driving Pressure Protocol

EXPERIMENTAL

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

Device: Ventilator

Interventions

Ventilator 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.

Also known as: Breathing Machine, Invasive mechanical ventilation

Low Driving Pressure Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
• Patient that is a potential ECMO candidate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Health

La Jolla, California, 92037-7381, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Heart Failure; Respiratory Insufficiency; Renal Insufficiency; Critical Illness; Lung Diseases; Ventilator-Induced Lung Injury

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Robert L Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine

Model Details: Single group, intervention

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: April 14, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)