Critical Illness Polyneuropathies
Conditions
Keywords
prolonged mechanical ventilation, critically ill patients, anabolic steroid
Brief summary
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.
Detailed description
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.
Interventions
DRUGTestosterone cypionate
Bi-weekly intramuscular injection of testosterone cypionate 200mg.
OTHERStandard nutrition and physical therapy at ICU
follow-up of the patient without use of testosterone cypionate
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals older than 18 years * Mechanical ventilation by orotracheal tube for more than 14 consecutive days * Mechanical ventilation by tracheostomy for more than 8 consecutive days
Exclusion criteria
* End of life care * Known hypersensitivity to formula * Venous or arterial thrombosis within last 6 months: ischemic stroke, myocardial infarction, acute peripheral arterial occlusion, acute mesenteric ischemia, deep venous thromboembolism, pulmonary embolism * Decompensated congestive heart failure * Acute liver failure or acute on chronic liver failure * Refractory shock (norepinephrine dose \>0.3 mcg/kg/min or equivalent doses of any vasoactive agent) * Platelets below \<20,000 / mm3 without transfusion plan * Personal history of prostate cancer * Primary neuromuscular disorders such as myasthenia gravis, Guillain-Barré syndrome, amyotrophic lateral sclerosis, Duchenne Muscular dystrophy * Current or prior spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation dependence | 8 weeks | Days of any positive pressure ventilation described in the patient record from the start of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle weakness | 8 weeks | The muscle weakness measured weekly by the study team through the Medical Research Council (MRC) |
| Ultrasound diaphragm | 8 weeks | Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration. |
| ICU length of stay | 9 months | Patient's length of stay in the intensive care unit after the start of the study as described in the patient record |
| Hospital length of stay | 9 months | Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record |
Countries
Brazil
Contacts
Primary ContactSara C Rosa
Backup ContactAna Carolina P Antonio, PhD
Outcome results
None listed