RECRUITING

Treatment of ARDS With Instilled T3

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Conditions

ARDS, HumanLung, WetThyroidPulmonary EdemaLung Inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

It is hypothesized that instillation of Liothyronine Sodium (T3) into the airspace will be safe, well tolerated, and will increase alveolar fluid clearance and decrease inflammation in patients with ARDS, reflected in improved oxygenation index (OI) and oxygenation saturation index (OSI).

Official Title

PHASE II RANDOMIZED, INTERVENTION VERSUS NON- INTERVENTION, MULTI- CENTER STUDY OF THE EFFECTS OF THYROID HORMONE (T3) ON SAFETY/TOLERABILITY AND OXYGENATION IN SUBJECTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

Quick Facts

Study Start:2019-10-21
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04115514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥18 years of age).
  2. * Male or female (non-pregnant).
  3. * Clinical diagnosis of ARDS (all are required):
  4. 1. Onset: \<= 7 days.
  5. 2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates.
  6. 3. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O.
  7. 4. Pulmonary Edema: Not fully explained by cardiogenic etiology.
  8. 5. Hypoxia: PaO2/FIO2 Ratio \<300, or O2Sat/FIO2 Ratio \<315.
  9. * On mechanical ventilatory support.
  10. * 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.
  1. * Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators.
  2. * Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status.
  3. * Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
  4. * Prior history of cardiovascular disease defined as:
  5. 1. Hypertensive crisis in the past 3 months (systolic \>200, or diastolic \>120 mmHg),
  6. 2. Sustained ventricular arrhythmia in the past 3 months (duration \>30 seconds)
  7. 3. Coronary artery disease (documented \>=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
  8. 4. Cardiac-related angina pectoris (\>=2 episodes in the past 3 months)
  9. 5. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of \>1mm in contiguous leads).
  10. 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.
  11. 7. Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
  12. * Currently pregnant or breastfeeding.
  13. * Known allergy to study drug.

Contacts and Locations

Study Contact

Melissa Rhodes
CONTACT
frak0001@umn.edu

Principal Investigator

Timothy P Rich, MD
STUDY_DIRECTOR
University of Minnesota
David H Ingbar, MD
STUDY_CHAIR
University of Minnesota
Ronald A Reikoff, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

M Health Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Timothy P Rich, MD, STUDY_DIRECTOR, University of Minnesota
  • David H Ingbar, MD, STUDY_CHAIR, University of Minnesota
  • Ronald A Reikoff, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-21
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2019-10-21
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • ARDS, Human
  • Lung, Wet
  • Thyroid
  • Pulmonary Edema
  • Lung Inflammation