TESTO-TRIAL: Randomized Clinical Trial on the Use of Testosterone in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Ventilator-free days at 28 days, starting from the date of randomization.
研究概览
简要总结
The objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days
详细描述
It will be a randomized, controlled, double-blind, single-center clinical trial conducted in the Intensive Care Unit (ICU) of the State Hospital of Serrana (HE Serrana). Patients admitted to the ICU who meet the eligibility criteria and have given written informed consent will be randomized into control and intervention groups. Forty-seven patients will be included in each group, totaling 94 patients. The intervention group will receive 200 mg of testosterone cypionate intramuscularly every 5 days for a total of 3 doses. The control group will receive a placebo on the same schedule. After inclusion in the study, demographic and clinical data, laboratory results, ultrasonographic measurements, and functionality and muscle strength scores will be assessed on days 1, 5, 10, and 15 in the ICU and until hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All assistant team members (physicians, pharmacists, nurses, etc.) and statisticians responsible for the analyses will remain blind to the identity of the treatments throughout the study.
The placebo (sesame oil) will be prepared in a similar packaging and with a volume identical to that of testosterone cypionate.
If a patient experiences an adverse effect potentially related to the medication, the attending physician may request to break the study blinding.
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
- •Patients on mechanical ventilation (MV) for seven days or more, or patients on MV with an unsuccessful weaning attempt for at least three days. An unsuccessful weaning attempt is defined as the patient undergoing a Spontaneous Breathing Trial (SBT) on three different days without success, according to the ICU protocol;
- •Over 18 years old;
- •Patients with optimized nutritional therapy, defined by caloric and protein goals met for at least three days;
- •Signing the informed consent form (ICF).
排除标准
- •Hypersensitivity to the medication, the vehicle of the medication, or the placebo (sesame oil);
- •Venous or arterial thrombosis in the past six months, including acute myocardial infarction, ischemic stroke, acute arterial occlusion, mesenteric ischemia, venous thromboembolism, or pulmonary embolism;
- •Left Ventricular Ejection Fraction (LVEF) below 35%;
- •Glutamic-pyruvic transaminase/Alanine Aminotransferase (GPT/ALT) greater than five times the normal level and impaired bilirubin excretion;
- •Patients with liver cirrhosis (CHILD > B);
- •Pregnant or lactating women;
- •Women of childbearing age;
- •Hematocrit >52%;
- •Refractory shock, defined as requiring a norepinephrine dose > 0.5 mcg/kg/min or a vasopressin dose > 0.04 IU/min;
- •Thrombocytopenia < 20,000/mm³ without a transfusion plan;
- •Personal history of prostate or breast cancer;
- •Active neoplasm of any site;
- •Primary neuromuscular disease, including Amyotrophic Lateral Sclerosis (ALS), Duchenne muscular dystrophy, myasthenia gravis, or Guillain-Barré syndrome;
- •Current or previous spinal cord injury above C4 (tetraplegia);
- •Patients with total limitation of therapeutic measures;
研究组 & 干预措施
Testosterone
Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses.
干预措施: Testosterone cypionate (200mg/3ml) (Drug)
Sesame oil
Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses.
干预措施: Sesame oil (3ml) (Other)
结局指标
主要结局
Ventilator-free days at 28 days, starting from the date of randomization.
时间窗: 28 days
Evaluate whether the use of the anabolic steroid testosterone cypionate, compared to a placebo, increases the number of ventilator-free days in critically ill patients.
次要结局
- Skeletal muscle assessment: Medical Research Council Sum-Score (MRC-SS).(Hospital stay, assessed up to 8 weeks.)
- Skeletal muscle assessment: dynamometry.(Hospital stay, assessed up to 8 weeks.)
- Skeletal muscle assessment: calf circumference.(Hospital stay, assessed up to 8 weeks.)
- Functionality and quality of life of critically ill patients during hospital stay: ICU Mobility Scale.(Hospital stay, assessed up to 8 weeks.)
- Functionality and quality of life of critically ill patients during hospital stay: Perme Intensive Care Unit Mobility Score.(Hospital stay, assessed up to 8 weeks.)
- Functionality and quality of life of critically ill patients during hospital stay: FSS-ICU (Functional Status Score for the Intensive Care Unit).(Hospital stay, assessed up to 8 weeks.)
- Functionality and quality of life of critically ill patients during hospital stay: TUG (Timed Up and Go).(Hospital stay, assessed up to 8 weeks.)
- Correlation of serum testosterone levels, clinical characteristics, and demographics of patients.(Hospital stay, assessed up to 8 weeks.)
- Correlation with serum levels of hemoglobin and hematocrit, in addition to patients clinical characteristics.(Hospital stay, assessed up to 8 weeks.)
- Correlation with serum albumin levels and patients clinical characteristics.(Hospital stay, assessed up to 8 weeks.)
- Functionality and quality of life of critically ill patients during hospital stay: the Barthel Index.(Hospital stay, assessed up to 8 weeks.)
- Quality of life of critically ill patients during hospital stay: EQ-5D (EuroQol 5-Dimension).(Hospital stay, assessed up to 8 weeks.)
- Length of stay in the hospital, measured in days.(ICU and hospital stay, assessed up to 8 weeks.)
- Length of stay in the ICU, measured in days.(ICU and hospital stay, assessed up to 8 weeks.)
- Ventilator weaning time in days, starting from the date of randomization.(ICU stay, assessed up to 8 weeks.)
- In-hospital mortality from any cause.(Hospital stay, assessed up to 8 weeks.)
- Sequential Organ Failure Assessment (SOFA) score during the ICU stay, starting from the date of randomization.(ICU stay, assessed up to 8 weeks.)
- Diaphragmatic muscle thickness.(Hospital stay, assessed up to 8 weeks)
- Diaphragmatic thickening fraction.(Hospital stay, assessed up to 8 weeks)
- Skeletal muscle assessment: quadriceps thickness.(Hospital stay, assessed up to 8 weeks.)
研究者
Leticia Maria Defendi Barboza Marson
PhD student
University of Sao Paulo