TESTO-TRIAL: Use of Testosterone in Critically Ill Patients

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.

Evaluate the effects of testosterone cypionate use on the length of hospital stays.

Evaluate the effects of testosterone cypionate use on the length of ICU (Intensive Care Unit) stays.

Evaluate the effects of testosterone cypionate use on the duration of mechanical ventilation.

Evaluate the effects of testosterone cypionate use on in-hospital mortality.

Evaluate the effects of using testosterone cypionate on the SOFA score during ICU hospitalization. This score is used to assess the degree of organ dysfunction in the patient, with scores ranging from 0 to 24 points; the higher the score, the greater the severity and risk of mortality in critically ill patients.

Evaluate the effects of using testosterone cypionate on the diaphragmatic muscle during hospitalization by measuring diaphragm thickness (in millimeters) through ultrasonography.

Evaluate the effects of using testosterone cypionate on the diaphragmatic muscle during hospitalization through ultrasonography. The thickening fraction is calculated using the following equation: (Final inspiratory diaphragm thickness - Final expiratory diaphragm thickness)/Final expiratory diaphragm thickness × 100. If the result is greater than 36%, it predicts successful weaning from mechanical ventilation.

Evaluate the effects of using testosterone cypionate on the thickness of the rectus femoris muscle by measuring its thickness at maximum and minimum compression through ultrasonographic analysis.

Evaluate the effects of testosterone cypionate on muscle strength gain using the MRC, which scores muscle strength from 0 (no contraction) to 5 (normal muscle contraction) for shoulder flexors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors, totaling 60 points.

Evaluate the effects of testosterone on muscle strength gain by measuring handgrip strength using dynamometry with the JAMAR dynamometer.

Evaluate the effects of testosterone on muscle mass gain indirectly by measuring calf circumference (in centimeters).

Evaluate the effects of testosterone cypionate use on functionality scores, including the ICU Mobility Scale (IMS) to objectively measure the mobility of patients in the ICU. This scale has a score ranging from 0 to 10, where a score of zero indicates low mobility (interpreted as a patient who only performs passive bed exercises) and a score of 10 indicates high mobility (interpreted as a patient who is independently ambulatory, without assistance).

Perme Intensive Care Unit Mobility Score objectively measures the mobility condition of a patient in the ICU. This mobility scale has a score ranging from 0 to 32 points, divided into 15 items grouped into 7 categories: mental state, potential barriers to mobility, functional strength, bed mobility, transfers, assistive devices for ambulation, and endurance measures. In this scale, a higher score indicates greater mobility and less need for assistance. Conversely, a lower score indicates reduced mobility and a greater need for assistance.

Evaluate the effects of testosterone on the functionality of critically ill patients using the FSS-ICU, a tool that involves five functional tasks (rolling, transferring from supine to sitting, transferring from sitting to standing, sitting on the edge of the bed, and walking). Each task is assessed using an 8-point ordinal scale, ranging from 0 (completely unable to perform) to 7 (complete independence).

Evaluate the effects of testosterone cypionate use on functionality scores, including the TUG (Timed Up and Go). The parameter evaluated is the time spent (in seconds) to rise from a chair, walk a distance of 3 meters, and return to sit down. The test is considered normal when the time taken is less than 10 seconds. If the time is between 10 and 19 seconds, the elderly person is considered to have a moderate risk of falling, and this risk increases when the time is 20 seconds or more.

Evaluate the correlation between patients clinical and demographic characteristics, as well as free testosterone serum levels in the placebo and intervention groups.

Evaluate the correlation between patients clinical and demographic characteristics and laboratory test levels, about the use of testosterone and the stimulation of erythropoietin production, leading to an increase in red blood cell production and, consequently, an increase in hemoglobin (normal value: 12.5 to 17.2 g/dL) and hematocrit (37-49%).

Evaluate the correlation between patients clinical and demographic characteristics and laboratory test levels, considering the affinity of total testosterone to albumin (normal value: 3.2 to 4.8 g/dL).

Evaluate the effects of using testosterone cypionate on functionality scores, including the Barthel Index at hospital discharge. The Barthel Index consists of ten items, such as feeding, transferring from bed to chair and back, personal hygiene, using the toilet, bathing, walking on a flat surface, stairs, dressing, fecal continence, and bladder continence. Each item has variable scores ranging from zero to fifteen points, depending on the individuals level of functional dependence. The maximum score is 100, which is assigned only if the patient does not require any assistance.

Evaluate the effects of testosterone cypionate use on quality of life, including the EQ-5D (EuroQol 5-Dimension) at hospital discharge.

The EQ-5D includes five levels of response for each of the five variables assessed: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each variable is scored from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The final score is a combination of the numbers assigned to each variable, resulting in a five-digit code that represents the patients health status.