NCT06592144

TESTO-TRIAL: Use of Testosterone in Critically Ill Patients

TESTO-TRIAL: Randomized Clinical Trial on the Use of Testosterone in Critically Ill Patients

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Leticia Maria Defendi Barboza Marson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Weaning Failure
• Muscle Weakness
• Mechanical Ventilation Complication
• ICU Acquired Weakness
• Mobility Limitation

Interventions

Type	Name	Description
DRUG	Testosterone cypionate (200mg/3ml)	It will be administered intramuscularly every 5 days, totaling 3 doses.
OTHER	Sesame oil (3ml)	It will be administered intramuscularly every 5 days, totaling 3 doses.

Timeline

• Start date: 2024-09-09
• Primary completion: 2026-08-02
• Completion: 2026-11-02
• First posted: 2024-09-19
• Last updated: 2024-12-18

Locations

1 site across 1 country: Brazil