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Treatment of ARDS With Instilled T3 (ARDS+T3)

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ClinicalTrials.gov Identifier: NCT04115514
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
It is hypothesized that instillation of (T3) into the airspace will increase alveolar fluid clearance in patients with ARDS, resulting in reduced extravascular lung water (EVLW).

Condition or disease Intervention/treatment Phase
ARDS, Human Lung, Wet Thyroid Pulmonary Edema Lung Inflammation Drug: Liothyronine Sodium (T3) (modified formulation) Phase 1 Phase 2

Detailed Description:

Randomized, unblinded, intervention versus non-intervention trial

Purpose: To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on EVLW index in ARDS patients.

Liothyronine Sodium (T3), 5-10-25-50µg will be instilled via catheter through ETT into the airways in a total volume of 10 ml (T3+0.9% sodium chloride) over 4 days (96 hours) with progressive dosing.

68 participants [50 treatment + 18 controls] will be investigated over 18 months or until target enrollment is achieved. No research intervention will occur with control subjects. Control subjects will receive standard of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, unblinded, intervention versus non-intervention trial. 68 [50 treatment + 18 controls]
Masking: None (Open Label)
Masking Description: None applicable
Primary Purpose: Treatment
Official Title: Phase II Randomized, Intervention Versus Non-Intervention, Multi-center Study of the Effects of Thyroid Hormone (T3) on Extravascular Lung Water (EVLW) in Subjects With Acute Respiratory Distress Syndrome (ARDS)
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : October 10, 2023
Estimated Study Completion Date : October 10, 2023


Arm Intervention/treatment
Experimental: Active treatment
Liothyronine Sodium (T3), 5-10-25-50µg instilled directly into the airways in a total volume of 10 ml (T3+0.9% sodium chloride). Progressive dosing every 24 hours for total 96 hours.
Drug: Liothyronine Sodium (T3) (modified formulation)
Liothyronine Sodium (T3), 5-10-25-50µg instilled directly into the airways in a total volume of 10 ml (T3+0.9% sodium chloride). Progressive dosing every 24 hours for total 96 hours.

No Intervention: Control arm
Standard of Care



Primary Outcome Measures :
  1. Change in Extravascular Lung Water Index (EVLWI) [ Time Frame: baseline, 1 hour post T3 installation ]
    EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.

  2. Change in Extravascular Lung Water Index (EVLWI) [ Time Frame: baseline, 12 hours post T3 installation ]
    EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 12 hours post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.

  3. Change in Extravascular Lung Water Index (EVLWI) [ Time Frame: baseline, 24 hours post T3 installation ]
    EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 24 hours post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.


Secondary Outcome Measures :
  1. Change in Arterial Oxygenation [ Time Frame: On clinically indicated ABGs (about 1 hour after admission), then 24 hours post T3 installation ]
    Arterial partial pressure of oxygen will be sampled by arterial catheter (reported as mmHg) upon admission and then 24 hours after the first dose of T3 to calculate change in arterial partial pressure of oxygen. Increased arterial partial pressure of oxygen indicates greater treatment efficacy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnosis of ARDS:

  • Chest x-ray: bilateral pulmonary infiltrates
  • Hypoxemia: PaO2:FIO2 ratio <200
  • Volume status: wedge and CVP<18

Main inclusion criteria:

  • Adults (≥18 years of age), non-pregnant
  • On mechanical ventilatory support

Exclusion Criteria:

  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. Active drug/alcohol use with positive drug screen or alcohol level on admission.
  4. Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
  5. Prior history of cardiovascular disease including:

    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 >50% occlusion in any coronary vessel)
    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), or positive cardiac enzymes (Ratio of CK-MB: Total CK > 3.5).
    6. Peripheral vascular disease (documented >50% occlusion in any peripheral vessel).
    7. Moderate or severe ischemic/non-ischemic cardiomyopathy (documented ejection fraction < 40%).
    8. Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
  6. Currently pregnant or breastfeeding.
  7. Currently taking tricyclic antidepressants, glycosides, ketamine, or vasopressors with ongoing evidence of myocardial ischemia.
  8. Known allergy to study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115514


Contacts
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Contact: Kelly M McCormick, MBA, MSL 6126243315 kmmccorm@umn.edu
Contact: Melisa A Bailey, MS 6126242627 baile807@umn.edu

Locations
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United States, Minnesota
Essentia Health - St. Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Christine Leone       Christine.Leone@essentiahealth.org   
Principal Investigator: Timothy P Rich, MD         
M Health Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: David Ingbar, MD         
East Bank Hospital - M Health Fairview University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: David Ingbar, MD         
M Health Fairview St. Joseph's Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: David Ingbar, MD         
M Health Fairview Bethesda Hospital Recruiting
Saint Paul, Minnesota, United States, 55103
Contact: David Ingbar, MD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Timothy P Rich, MD University of Minnesota
Study Chair: David H Ingbar, MD University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04115514    
Other Study ID Numbers: 036127
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Pulmonary Edema
Respiratory Distress Syndrome
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Respiratory Tract Infections
Infections