The researchers intend to investigate possible anabolic effects of bi-weekly exogenous testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control group will receive standard ICU management and will also be followed during ICU stay.
For the study chronic critical patients will be included according to criterion of mechanical ventilation by orotracheal tube\> 14 consecutive days or mechanical ventilation by tracheostomy\> 8 consecutive days and that do not present exclusion criteria. Patients will be randomized into two follow-up groups: Intervention group with anabolic steroid and control group. The anabolic steroid intervention group will receive a bi-weekly dose of 200mg intramuscular testosterone cypionate and receive the standard treatment of nutritional therapy and physical therapy. While patients in the control group will receive only the standard treatment of nutrition and physical therapy, without addition of the anabolic drug. At the beginning of the study and weekly the patients will be evaluated in relation to the muscular profile with diaphragm ultrasound and Medical Research Council (MRC) application. In addition to the collection of serum homograms, leukogram, lipid profile and renal function tests. Weight and nutritional therapy-related data will be identified in the patient's chart regarding caloric and protein requirement and supply adequacy. In the inclusion and biweekly will be collected serum levels of free testosterone, blood count, leukogram, blood gas, renal function and liver function. Nitrogen balance of patients from urinary urea will be performed. The evaluations of the groups and the intervention with the anabolic steroid will be of 8 weeks or during the period of dependence of the mechanical ventilation. After this period the patients will be monitored for the outcome: length of stay in the intensive care unit, hospital stay until discharge and clinical outcome: death or discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bi-weekly intramuscular injection of testosterone cypionate 200mg.
follow-up of the patient without use of testosterone cypionate
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGMechanical ventilation dependence
Days of any positive pressure ventilation described in the patient record from the start of the study
Time frame: 8 weeks
Muscle weakness
The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)
Time frame: 8 weeks
Ultrasound diaphragm
Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration.
Time frame: 8 weeks
ICU length of stay
Patient's length of stay in the intensive care unit after the start of the study as described in the patient record
Time frame: 9 months
Hospital length of stay
Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record
Time frame: 9 months
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