Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness (RAS-ICU)

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Critical Illness Polyneuropathies

Treatments: Drug: Testosterone cypionate; Other: Standard nutrition and physical therapy at ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT03038919

16-0293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Anabolic patients

Experimental group

Description:

Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.

Treatment:

Other: Standard nutrition and physical therapy at ICU

Drug: Testosterone cypionate

Control

Other group

Description:

Standard nutrition and physical therapy at ICU without administration of testosterone cypionate

Treatment:

Other: Standard nutrition and physical therapy at ICU