Status:
ACTIVE_NOT_RECRUITING
TESTO-TRIAL: Use of Testosterone in Critically Ill Patients
Lead Sponsor:
Leticia Maria Defendi Barboza Marson
Conditions:
Weaning Failure
Muscle Weakness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06592144
Start Date
September 9 2024
End Date
November 2 2026
Last Update
December 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Estadual Serrana
Serrana, SP/Brazil, Brazil, 14150-000