TESTO-TRIAL: Use of Testosterone in Critically Ill Patients (TT)

Leticia Maria Defendi Barboza Marson

Status and phase: Active, not recruiting; Phase 4

Conditions: Weaning Failure; Mechanical Ventilation Complication; Muscle Weakness; Mobility Limitation; ICU Acquired Weakness

Treatments: Drug: Testosterone cypionate (200mg/3ml); Other: Sesame oil (3ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT06592144

CAAE76790723.5.0000.5440072024

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

94 participants in 2 patient groups, including a placebo group

Testosterone

Experimental group

Description:

Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses.

Treatment:

Drug: Testosterone cypionate (200mg/3ml)

Sesame oil

Placebo Comparator group

Description:

Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses.

Treatment:

Other: Sesame oil (3ml)