NCT03038919

Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness Polyneuropathies

Interventions

Type	Name	Description
DRUG	Testosterone cypionate	Bi-weekly intramuscular injection of testosterone cypionate 200mg.
OTHER	Standard nutrition and physical therapy at ICU	follow-up of the patient without use of testosterone cypionate

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-10-01
• Completion: 2018-01-01
• First posted: 2017-02-01
• Last updated: 2017-02-01

Locations

1 site across 1 country: Brazil