Back to resultsTreatment of ARDS With Instilled T3 (ARDS+T3)
Primary Purpose
ARDS, Human, Lung, Wet, Thyroid
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liothyronine Sodium (T3) (modified formulation)
Sponsored by
About this trial
This is an interventional treatment trial for ARDS, Human
Eligibility 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:
- 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.
- Active drug/alcohol use with positive drug screen or alcohol level on admission.
- 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 including:
- Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),
- Sustained ventricular arrhythmia in the past 3 months (duration > 30 seconds)
- Coronary artery disease (documented >50% occlusion in any coronary vessel)
- Cardiac-related angina pectoris (> 2 episodes in the past 3 months)
- 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).
- Peripheral vascular disease (documented >50% occlusion in any peripheral vessel).
- Moderate or severe ischemic/non-ischemic cardiomyopathy (documented ejection fraction < 40%).
- 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.
- Currently taking tricyclic antidepressants, glycosides, ketamine, or vasopressors with ongoing evidence of myocardial ischemia.
- Known allergy to study drug.
Sites / Locations
- Essentia Health - St. Mary's Medical CenterRecruiting
- M Health Fairview Southdale HospitalRecruiting
- East Bank Hospital - M Health Fairview University of Minnesota Medical CenterRecruiting
- M Health Fairview St. Joseph's HospitalRecruiting
- M Health Fairview Bethesda HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active treatment
Control arm
Arm Description
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.
Standard of Care
Outcomes
Primary Outcome Measures
Change in Extravascular Lung Water Index (EVLWI)
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.
Change in Extravascular Lung Water Index (EVLWI)
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.
Change in Extravascular Lung Water Index (EVLWI)
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
Change in Arterial Oxygenation
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.
Full Information
NCT ID
NCT04115514
First Posted
March 12, 2019
Last Updated
October 2, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04115514
Brief Title
Treatment of ARDS With Instilled T3
Acronym
ARDS+T3
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, unblinded, intervention versus non-intervention trial. 68 [50 treatment + 18 controls]
Masking
None (Open Label)
Masking Description
None applicable
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Liothyronine Sodium (T3) (modified formulation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Extravascular Lung Water Index (EVLWI)
Description
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.
Time Frame
baseline, 1 hour post T3 installation
Title
Change in Extravascular Lung Water Index (EVLWI)
Description
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.
Time Frame
baseline, 12 hours post T3 installation
Title
Change in Extravascular Lung Water Index (EVLWI)
Description
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.
Time Frame
baseline, 24 hours post T3 installation
Secondary Outcome Measure Information:
Title
Change in Arterial Oxygenation
Description
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.
Time Frame
On clinically indicated ABGs (about 1 hour after admission), then 24 hours post T3 installation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Active drug/alcohol use with positive drug screen or alcohol level on admission.
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 including:
Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),
Sustained ventricular arrhythmia in the past 3 months (duration > 30 seconds)
Coronary artery disease (documented >50% occlusion in any coronary vessel)
Cardiac-related angina pectoris (> 2 episodes in the past 3 months)
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).
Peripheral vascular disease (documented >50% occlusion in any peripheral vessel).
Moderate or severe ischemic/non-ischemic cardiomyopathy (documented ejection fraction < 40%).
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.
Currently taking tricyclic antidepressants, glycosides, ketamine, or vasopressors with ongoing evidence of myocardial ischemia.
Known allergy to study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly M McCormick, MBA, MSL
Phone
6126243315
Email
kmmccorm@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa A Bailey, MS
Phone
6126242627
Email
baile807@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy P Rich, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David H Ingbar, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald A Reikoff, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Essentia Health - St. Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Leone
Email
Christine.Leone@essentiahealth.org
First Name & Middle Initial & Last Name & Degree
Timothy P Rich, MD
Facility Name
M Health Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD
Facility Name
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD
Facility Name
M Health Fairview St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD
Facility Name
M Health Fairview Bethesda Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ingbar, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33127750
Citation
Flory CM, Norris BJ, Larson NA, Coicou LG, Koniar BL, Mysz MA, Rich TP, Ingbar DH, Schumacher RJ. A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. J Pharmacol Exp Ther. 2021 Jan;376(1):74-83. doi: 10.1124/jpet.120.000060. Epub 2020 Oct 30.
Results Reference
derived
Learn more about this trial
Treatment of ARDS With Instilled T3
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