Testosterone cypionate (200mg/3ml): It will be administered intramuscularly every 5 days, totaling 3 doses.
Sesame oil (3ml): It will be administered intramuscularly every 5 days, totaling 3 doses.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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;
Primary outcome measure(s)
Ventilator-free days at 28 days, starting from the date of randomization. — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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