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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
研究概览
简要总结
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).
详细描述
T3 Therapy in ARDS- Phase 2 Randomized, Unblinded, Intervention versus Non- Intervention Trial. Enrollment 68 participants (50 treatment + 18 control). Purpose- To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on Oxygenation in ARDS patients. Study Drug- Liothyronine Sodium (T3), 50 mcg will be instilled twice daily via a catheter through the ETT into the airway in a total volume of 10 mL (T3+0.9% sodium chloride), over 5 days (10 total doses), or until extubation, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None applicable
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •Onset: <= 7 days.
- •Chest x-ray: Bilateral Patchy Opacities, Infiltrates.
- •Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O.
- •Pulmonary Edema: Not fully explained by cardiogenic etiology.
- •Hypoxia: PaO2/FIO2 Ratio <300, or O2Sat/FIO2 Ratio <
- •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.
排除标准
- •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:
- •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 >=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
- •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).
- •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.
- •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.
研究组 & 干预措施
Treatment Arm
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
干预措施: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. (Drug)
Control arm
Standard of Care
干预措施: Non-intervention (Other)
结局指标
主要结局
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
时间窗: 120 hours post-dose
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
次要结局
- Cardiovascular event 4(baseline to 120hours post-dose)
- Cardiovascular event 5(baseline to 120hours post-dose)
- SOC diurectic(s) dose(s)(baseline and 5 days)
- Ventilator Free Days(baseline and 5 days)
- ICU Free Days(baseline and 5 days)
- Oxygen Free Days(baseline and 5 days)
- All-Cause Mortality(baseline and 5 days)
- Tracheostomy placement requirement(baseline and 5 days)
- Supplemental oxygen on discharge(baseline and 5 days)
- Discharge disposition(baseline and 5 days)
- Pulmonary events(baseline and 120 hours post-dose)
- Cardiovascular event 1(baseline to 120hours post-dose)
- Cardiovascular event 2(baseline to 120hours post-dose)
- Cardiovascular event 3(baseline to 120hours post-dose)
- SOC pressor(s) dose(s)(baseline and 5 days)
- SOC pulmonary vasodilator(baseline and 5 days)
- TSH, Total T3, Free T3, Free T4(baseline and 156-hrs post-dose)
- Free T3, Free T4(baseline and 5 days)