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

January 31, 2017 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sara C da Rosa
        • Sub-Investigator:
          • Ana Carolina P Antonio, PhD
        • Principal Investigator:
          • Silvia RR Vieira, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anabolic patients
Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU.
Drug: Testosterone cypionate
Bi-weekly intramuscular injection of testosterone cypionate 200mg.
Other Names:
  • testosterone
Other: Standard nutrition and physical therapy at ICU
follow-up of the patient without use of testosterone cypionate
Other: Control
Standard nutrition and physical therapy at ICU without administration of testosterone cypionate
Other: Standard nutrition and physical therapy at ICU
follow-up of the patient without use of testosterone cypionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation dependence
Time Frame: 8 weeks
Days of any positive pressure ventilation described in the patient record from the start of the study
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle weakness
Time Frame: 8 weeks
The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)
8 weeks
Ultrasound diaphragm
Time Frame: 8 weeks
Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration.
8 weeks
ICU length of stay
Time Frame: 9 months
Patient's length of stay in the intensive care unit after the start of the study as described in the patient record
9 months
Hospital length of stay
Time Frame: 9 months
Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Silvia RR Vieira, PhD, Hospital de Clínicas de Porto Alegre - RS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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