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

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ClinicalTrials.gov Identifier: NCT03038919
Recruitment Status : Unknown
Verified January 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Critical Illness Polyneuropathies Drug: Testosterone cypionate Other: Standard nutrition and physical therapy at ICU Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018


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 Name: testosterone

Other: Standard nutrition and physical therapy at ICU
follow-up of the patient without use of testosterone cypionate

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




Primary Outcome Measures :
  1. Mechanical ventilation dependence [ Time Frame: 8 weeks ]
    Days of any positive pressure ventilation described in the patient record from the start of the study


Secondary Outcome Measures :
  1. Muscle weakness [ Time Frame: 8 weeks ]
    The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038919


Contacts
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Contact: Sara C Rosa +5551997381047 sararosa92@gmail.com
Contact: Ana Carolina P Antonio, PhD +5551984428820 ana.carolina.antonio@gmail.com

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil
Contact: Ana Carolina P Antonio, PhD    +555133598000 ext 8637    aantonio@hcpa.edu.br   
Contact: Sara C Rosa    +555133598000 ext 8637    sararosa92@gmail.com   
Sub-Investigator: Sara C da Rosa         
Sub-Investigator: Ana Carolina P Antonio, PhD         
Principal Investigator: Silvia RR Vieira, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Silvia RR Vieira, PhD Hospital de Clínicas de Porto Alegre - RS
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03038919    
Other Study ID Numbers: 16-0293
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
prolonged mechanical ventilation
critically ill patients
anabolic steroid
Additional relevant MeSH terms:
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Polyneuropathies
Critical Illness
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents