Critical Illness PolyneuropathiesPhase 2/3RAS-ICUNCT03038919
Role of Anabolic Steroids on Intensive Care Unit-Acquired Weakness
A Phase 2/3 study testing Testosterone cypionate and Standard nutrition and physical therapy at ICU in people with Critical Illness Polyneuropathies, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Polyneuropathies
- What is being tested?
- Testosterone cypionate and Standard nutrition and physical therapy at ICU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Ana Carolina P Antonio, PhD, +555133598000 ext. 8637, aantonio@hcpa.edu.br
Sara C Rosa, +555133598000 ext. 8637, sararosa92@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Testosterone cypionate, Standard nutrition and physical therapy at ICU
- Keywords
- prolonged mechanical ventilation, critically ill patients, anabolic steroid
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionateDrug
Also called testosterone
Bi-weekly intramuscular injection of testosterone cypionate 200mg.
Standard nutrition and physical therapy at ICUOther
follow-up of the patient without use of testosterone cypionate
| Study group | Role | What they receive |
|---|---|---|
| Anabolic patients | Experimental | Intramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU. Receives: Drug: Testosterone cypionate; Other: Standard nutrition and physical therapy at ICU |
| Control | Other | Standard nutrition and physical therapy at ICU without administration of testosterone cypionate Receives: Other: Standard nutrition and physical therapy at ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation dependence
Days of any positive pressure ventilation described in the patient record from the start of the study
Measured: 8 weeks
Secondary outcomes (4)
Muscle weakness
The muscle weakness measured weekly by the study team through the Medical Research Council (MRC)
Measured: 8 weeks
Ultrasound diaphragm
Weekly the study team will perform diaphragm ultrasound to monitor the respiratory muscles, observing measures of inspiration and expiration.
Measured: 8 weeks
ICU length of stay
Patient's length of stay in the intensive care unit after the start of the study as described in the patient record
Measured: 9 months
Hospital length of stay
Period of stay of the patient in the hospital after discharge from the intensive care unit described in the patient record
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness PolyneuropathiesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia RR Vieira, PhD, Principal investigator, Hospital de Clínicas de Porto Alegre - RS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038919
- Sponsor's protocol ID
- 16-0293
- Acronym
- RAS-ICU
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03038919
- Acronym / sponsor ID
- RAS-ICU / 16-0293
- Conditions
- Critical Illness Polyneuropathies
- Keywords
- prolonged mechanical ventilation, critically ill patients, anabolic steroid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anabolic patients | Experimental | Drug: Testosterone cypionate, Other: Standard nutrition and physical therapy at ICUIntramuscular injection of testosterone cypionate 200mg every 15 days in addition to standard nutrition and physical therapy at ICU. |
| Control | Other | Other: Standard nutrition and physical therapy at ICUStandard nutrition and physical therapy at ICU without administration of testosterone cypionate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone cypionateAlso: testosteroneBi-weekly intramuscular injection of testosterone cypionate 200mg. | Drug | Anabolic patients |
| Standard nutrition and physical therapy at ICUfollow-up of the patient without use of testosterone cypionate | Other | Anabolic patients, Control |
Primary outcome
Mechanical ventilation dependence
Time frame: 8 weeks
Days of any positive pressure ventilation described in the patient record from the start of the study
4 secondary outcomes
Muscle weakness
Time frame: 8 weeks
Ultrasound diaphragm
Time frame: 8 weeks
ICU length of stay
Time frame: 9 months
Hospital length of stay
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia RR Vieira, PhD principal investigator
Hospital de Clínicas de Porto Alegre - RS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Testosterone cypionate and Standard nutrition and physical therapy at ICU in people with Critical Illness Polyneuropathies, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara C Rosa (+5551997381047, sararosa92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation dependence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.