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NCT04669444Active, not recruiting

Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

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

Source: ClinicalTrials.gov · Last updated 26 Jan 2023

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
9 Dec 2020
Start date
14 Apr 2020
Primary completion date
1 Mar 2022
Lead sponsor
University of California, San Diego
NCT number
NCT04669444

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 14 Apr 2020 to the primary completion date, 1 Mar 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of Lung or Cardiac Transplantation

Other

  • 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.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Diego Health
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.