Clinical trial NCT03038919: Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness
Official title: Pilot Randomized, Controlled Trial of Testosterone Therapy in Chronic Critically Ill Patients and Its Potential Effects on Weaning From Mechanical Ventilation and Intensive Care Unit-acquired Weakness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Critical Illness Polyneuropathies
Keywords: prolonged mechanical ventilation
critically ill patients
anabolic steroid
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical ventilation dependence
timeFrame: 8 weeks
Secondary outcomes:
measure: Muscle weakness
timeFrame: 8 weeks
measure: Ultrasound diaphragm
timeFrame: 8 weeks
measure: ICU length of stay
timeFrame: 9 months
measure: Hospital length of stay
timeFrame: 9 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre - RS
name: Silvia RR Vieira, PhD
role: PRINCIPAL_INVESTIGATOR
References: