Treatment of ARDS With Instilled T3

Launched by UNIVERSITY OF MINNESOTA · Oct 2, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Liothyronine Sodium (T3) can help patients with Acute Respiratory Distress Syndrome (ARDS) breathe better and reduce lung inflammation. ARDS is a serious condition that makes it hard for patients to get enough oxygen, often requiring mechanical ventilation in the ICU. The researchers believe that putting T3 directly into the lungs could help clear excess fluid and improve overall lung function, which might be reflected in better oxygen levels.

To participate in this study, patients must be adults who are critically ill and currently on a ventilator due to ARDS, with a specific diagnosis and certain clinical criteria. Unfortunately, those with a history of thyroid problems, serious heart conditions, or who are pregnant or breastfeeding cannot join. Participants will receive careful monitoring during the trial to ensure their safety and well-being. This study is currently looking for volunteers, and if you or a loved one fits the criteria, it could be an opportunity to contribute to important medical research while receiving potential new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.
• • Adults (≥18 years of age).
• • Male or female (non-pregnant).
• * Clinical diagnosis of ARDS (all are required):
• • 1. Onset: \<= 7 days.
• • 2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates.
• • 3. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O.
• • 4. Pulmonary Edema: Not fully explained by cardiogenic etiology.
• • 5. Hypoxia: PaO2/FIO2 Ratio \<300, or O2Sat/FIO2 Ratio \<315.
• • On mechanical ventilatory support.
• • Capable of giving informed consent directly or from the subject's legally authorized representative (LAR) as determined by the site Principal Investigator and/or Sub- Investigators.
• Exclusion Criteria:
• Patients with any of the following conditions will be excluded from this trial:
• • Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators.
• • Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status.
• • Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
• * Prior history of cardiovascular disease defined as:
• • 1. Hypertensive crisis in the past 3 months (systolic \>200, or diastolic \>120 mmHg),
• • 2. Sustained ventricular arrhythmia in the past 3 months (duration \>30 seconds)
• • 3. Coronary artery disease (documented \>=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
• • 4. Cardiac-related angina pectoris (\>=2 episodes in the past 3 months)
• • 5. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of \>1mm in contiguous leads).
• • 6. Peripheral vascular disease (documented \>=70% occlusion untreated in any peripheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines for Appropriate Use Criteria for Peripheral Artery Intervention.
• • 7. Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
• • Currently pregnant or breastfeeding.
• • Known allergy to study drug.