Weaning FailurePhase 4TTNCT06592144
TESTO-TRIAL: Use of Testosterone in Critically Ill Patients
A Phase 4 study testing Testosterone cypionate (200mg/3ml) and Sesame oil (3ml) in people with Weaning Failure and Muscle Weakness, run by Leticia Maria Defendi Barboza Marson at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Muscle Weakness, Mechanical Ventilation Complication
- What is being tested?
- Testosterone cypionate (200mg/3ml) and Sesame oil (3ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Sep 2024to 2 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients on mechanical ventilation (MV) for seven days or more, or patients on MV with an unsuccessful weaning attempt for at least three days. An unsuccessful weaning attempt is defined as the patient undergoing a Spontaneous Breathing Trial (SBT) on three different days without success, according to the ICU protocol;
- Over 18 years old;
- Patients with optimized nutritional therapy, defined by caloric and protein goals met for at least three days;
- Signing the informed consent form (ICF).
Who cannot join
- Hypersensitivity to the medication, the vehicle of the medication, or the placebo (sesame oil);
- Venous or arterial thrombosis in the past six months, including acute myocardial infarction, ischemic stroke, acute arterial occlusion, mesenteric ischemia, venous thromboembolism, or pulmonary embolism;
- Left Ventricular Ejection Fraction (LVEF) below 35%;
- Glutamic-pyruvic transaminase/Alanine Aminotransferase (GPT/ALT) greater than five times the normal level and impaired bilirubin excretion;
- Patients with liver cirrhosis (CHILD > B);
- Pregnant or lactating women;
Show all 15Show fewer
- Women of childbearing age;
- Hematocrit >52%;
- Refractory shock, defined as requiring a norepinephrine dose > 0.5 mcg/kg/min or a vasopressin dose > 0.04 IU/min;
- Thrombocytopenia < 20,000/mm³ without a transfusion plan;
- Personal history of prostate or breast cancer;
- Active neoplasm of any site;
- Primary neuromuscular disease, including Amyotrophic Lateral Sclerosis (ALS), Duchenne muscular dystrophy, myasthenia gravis, or Guillain-Barré syndrome;
- Current or previous spinal cord injury above C4 (tetraplegia);
- Patients with total limitation of therapeutic measures;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TESTO-TRIAL: Randomized Clinical Trial on the Use of Testosterone in Critically Ill Patients
The objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days
Read the detailed description
It will be a randomized, controlled, double-blind, single-center clinical trial conducted in the Intensive Care Unit (ICU) of the State Hospital of Serrana (HE Serrana). Patients admitted to the ICU who meet the eligibility criteria and have given written informed consent will be randomized into control and intervention groups. Forty-seven patients will be included in each group, totaling 94 patients. The intervention group will receive 200 mg of testosterone cypionate intramuscularly every 5 days for a total of 3 doses. The control group will receive a placebo on the same schedule. After inclusion in the study, demographic and clinical data, laboratory results, ultrasonographic measurements, and functionality and muscle strength scores will be assessed on days 1, 5, 10, and 15 in the ICU and until hospital discharge.
- Conditions
- Weaning Failure, Muscle Weakness, Mechanical Ventilation Complication, ICU Acquired Weakness, Mobility Limitation
- Being tested
- Testosterone cypionate (200mg/3ml), Sesame oil (3ml)
- Keywords
- Testosterone, Mechanical ventilation, Weaning, Critical Illness
- Medical subject headings
- Muscle Weakness, Mobility Limitation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionate (200mg/3ml)Drug
It will be administered intramuscularly every 5 days, totaling 3 doses.
Sesame oil (3ml)Other
It will be administered intramuscularly every 5 days, totaling 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses. Receives: Drug: Testosterone cypionate (200mg/3ml) |
| Sesame oil | Placebo comparator | Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses. Receives: Other: Sesame oil (3ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days at 28 days, starting from the date of randomization.
Evaluate whether the use of the anabolic steroid testosterone cypionate, compared to a placebo, increases the number of ventilator-free days in critically ill patients.
Measured: 28 days
Secondary outcomes (20)
Length of stay in the hospital, measured in days.
Evaluate the effects of testosterone cypionate use on the length of hospital stays.
Measured: ICU and hospital stay, assessed up to 8 weeks.
Length of stay in the ICU, measured in days.
Evaluate the effects of testosterone cypionate use on the length of ICU (Intensive Care Unit) stays.
Measured: ICU and hospital stay, assessed up to 8 weeks.
Ventilator weaning time in days, starting from the date of randomization.
Evaluate the effects of testosterone cypionate use on the duration of mechanical ventilation.
Measured: ICU stay, assessed up to 8 weeks.
In-hospital mortality from any cause.
Evaluate the effects of testosterone cypionate use on in-hospital mortality.
Measured: Hospital stay, assessed up to 8 weeks.
Sequential Organ Failure Assessment (SOFA) score during the ICU stay, starting from the date of randomization.
Evaluate the effects of using testosterone cypionate on the SOFA score during ICU hospitalization. This score is used to assess the degree of organ dysfunction in the patient, with scores ranging from 0 to 24 points; the higher the score, the greater the severity and risk of mortality in critically ill patients.
Measured: ICU stay, assessed up to 8 weeks.
Diaphragmatic muscle thickness.
Evaluate the effects of using testosterone cypionate on the diaphragmatic muscle during hospitalization by measuring diaphragm thickness (in millimeters) through ultrasonography.
Measured: Hospital stay, assessed up to 8 weeks
Diaphragmatic thickening fraction.
Evaluate the effects of using testosterone cypionate on the diaphragmatic muscle during hospitalization through ultrasonography. The thickening fraction is calculated using the following equation: (Final inspiratory diaphragm thickness - Final expiratory diaphragm thickness)/Final expiratory diaphragm thickness × 100. If the result is greater than 36%, it predicts successful weaning from mechanical ventilation.
Measured: Hospital stay, assessed up to 8 weeks
Skeletal muscle assessment: quadriceps thickness.
Evaluate the effects of using testosterone cypionate on the thickness of the rectus femoris muscle by measuring its thickness at maximum and minimum compression through ultrasonographic analysis.
Measured: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: Medical Research Council Sum-Score (MRC-SS).
Evaluate the effects of testosterone cypionate on muscle strength gain using the MRC, which scores muscle strength from 0 (no contraction) to 5 (normal muscle contraction) for shoulder flexors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors, totaling 60 points.
Measured: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: dynamometry.
Evaluate the effects of testosterone on muscle strength gain by measuring handgrip strength using dynamometry with the JAMAR dynamometer.
Measured: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: calf circumference.
Evaluate the effects of testosterone on muscle mass gain indirectly by measuring calf circumference (in centimeters).
Measured: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: ICU Mobility Scale.
Evaluate the effects of testosterone cypionate use on functionality scores, including the ICU Mobility Scale (IMS) to objectively measure the mobility of patients in the ICU. This scale has a score ranging from 0 to 10, where a score of zero indicates low mobility (interpreted as a patient who only performs passive bed exercises) and a score of 10 indicates high mobility (interpreted as a patient who is independently ambulatory, without assistance).
Measured: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: Perme Intensive Care Unit Mobility Score.
Perme Intensive Care Unit Mobility Score objectively measures the mobility condition of a patient in the ICU. This mobility scale has a score ranging from 0 to 32 points, divided into 15 items grouped into 7 categories: mental state, potential barriers to mobility, functional strength, bed mobility, transfers, assistive devices for ambulation, and endurance measures. In this scale, a higher score indicates greater mobility and less need for assistance. Conversely, a lower score indicates reduced mobility and a greater need for assistance.
Measured: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: FSS-ICU (Functional Status Score for the Intensive Care Unit).
Evaluate the effects of testosterone on the functionality of critically ill patients using the FSS-ICU, a tool that involves five functional tasks (rolling, transferring from supine to sitting, transferring from sitting to standing, sitting on the edge of the bed, and walking). Each task is assessed using an 8-point ordinal scale, ranging from 0 (completely unable to perform) to 7 (complete independence).
Measured: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: TUG (Timed Up and Go).
Evaluate the effects of testosterone cypionate use on functionality scores, including the TUG (Timed Up and Go). The parameter evaluated is the time spent (in seconds) to rise from a chair, walk a distance of 3 meters, and return to sit down. The test is considered normal when the time taken is less than 10 seconds. If the time is between 10 and 19 seconds, the elderly person is considered to have a moderate risk of falling, and this risk increases when the time is 20 seconds or more.
Measured: Hospital stay, assessed up to 8 weeks.
Correlation of serum testosterone levels, clinical characteristics, and demographics of patients.
Evaluate the correlation between patients clinical and demographic characteristics, as well as free testosterone serum levels in the placebo and intervention groups.
Measured: Hospital stay, assessed up to 8 weeks.
Correlation with serum levels of hemoglobin and hematocrit, in addition to patients clinical characteristics.
Evaluate the correlation between patients clinical and demographic characteristics and laboratory test levels, about the use of testosterone and the stimulation of erythropoietin production, leading to an increase in red blood cell production and, consequently, an increase in hemoglobin (normal value: 12.5 to 17.2 g/dL) and hematocrit (37-49%).
Measured: Hospital stay, assessed up to 8 weeks.
Correlation with serum albumin levels and patients clinical characteristics.
Evaluate the correlation between patients clinical and demographic characteristics and laboratory test levels, considering the affinity of total testosterone to albumin (normal value: 3.2 to 4.8 g/dL).
Measured: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: the Barthel Index.
Evaluate the effects of using testosterone cypionate on functionality scores, including the Barthel Index at hospital discharge. The Barthel Index consists of ten items, such as feeding, transferring from bed to chair and back, personal hygiene, using the toilet, bathing, walking on a flat surface, stairs, dressing, fecal continence, and bladder continence. Each item has variable scores ranging from zero to fifteen points, depending on the individuals level of functional dependence. The maximum score is 100, which is assigned only if the patient does not require any assistance.
Measured: Hospital stay, assessed up to 8 weeks.
Quality of life of critically ill patients during hospital stay: EQ-5D (EuroQol 5-Dimension).
Evaluate the effects of testosterone cypionate use on quality of life, including the EQ-5D (EuroQol 5-Dimension) at hospital discharge.
The EQ-5D includes five levels of response for each of the five variables assessed: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each variable is scored from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The final score is a combination of the numbers assigned to each variable, resulting in a five-digit code that represents the patients health status.
Measured: Hospital stay, assessed up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completion2 Aug 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses. Control Group: Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leticia Maria Defendi Barboza Marson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leticia Maria Defendi Barboza Marson, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592144
- Sponsor's protocol ID
- CAAE76790723.5.0000.5440072024
- Acronym
- TT
- Status last verified
- Dec 2024
- First submitted
- 27 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous participant data will be available upon completion of clinical trials and publication of the results of the completed study upon request to the corresponding author. Proposals will be reviewed and approved by the sponsor, researcher, and staff on the basis of scientific merit and absence of competing interests. After the proposal has been approved, data can only be shared through a secure online platform after data access code exchange and a confidentiality agreement are signed.
Publications
Wischmeyer PE, Suman OE, Kozar R, Wolf SE, Molinger J, Pastva AM. Role of anabolic testosterone agents and structured exercise to promote recovery in ICU survivors. Curr Opin Crit Care. 2020 Oct;26(5):508-515. doi: 10.1097/MCC.0000000000000757.
PubMed 32773614Stanojcic M, Finnerty CC, Jeschke MG. Anabolic and anticatabolic agents in critical care. Curr Opin Crit Care. 2016 Aug;22(4):325-31. doi: 10.1097/MCC.0000000000000330.
PubMed 27272101Anstey MH, Rauniyar R, Fitzclarence E, Tran N, Osnain E, Mammana B, Jacques A, Palmer RN, Chapman A, Wibrow B. Muscle Growth and Anabolism in Intensive Care Survivors (GAINS) trial: a pilot randomised controlled trial. Acute Crit Care. 2022 Aug;37(3):295-302. doi: 10.4266/acc.2021.01767. Epub 2022 Jun 27.
PubMed 35791659Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.
PubMed 20592293Anstey M, Desai S, Torre L, Wibrow B, Seet J, Osnain E. Anabolic Steroid Use for Weight and Strength Gain in Critically Ill Patients: A Case Series and Review of the Literature. Case Rep Crit Care. 2018 May 7;2018:4545623. doi: 10.1155/2018/4545623. eCollection 2018.
PubMed 29854477Li H, Guo Y, Yang Z, Roy M, Guo Q. The efficacy and safety of oxandrolone treatment for patients with severe burns: A systematic review and meta-analysis. Burns. 2016 Jun;42(4):717-27. doi: 10.1016/j.burns.2015.08.023. Epub 2015 Oct 9.
PubMed 26454425Dres M, Demoule A. Diaphragm dysfunction during weaning from mechanical ventilation: an underestimated phenomenon with clinical implications. Crit Care. 2018 Mar 20;22(1):73. doi: 10.1186/s13054-018-1992-2.
PubMed 29558983Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
PubMed 27620292Haaksma ME, Smit JM, Boussuges A, Demoule A, Dres M, Ferrari G, Formenti P, Goligher EC, Heunks L, Lim EHT, Mokkink LB, Soilemezi E, Shi Z, Umbrello M, Vetrugno L, Vivier E, Xu L, Zambon M, Tuinman PR. EXpert consensus On Diaphragm UltraSonography in the critically ill (EXODUS): a Delphi consensus statement on the measurement of diaphragm ultrasound-derived parameters in a critical care setting. Crit Care. 2022 Apr 8;26(1):99. doi: 10.1186/s13054-022-03975-5.
PubMed 35395861Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
PubMed 33237154Santangelo E, Mongodi S, Bouhemad B, Mojoli F. The weaning from mechanical ventilation: a comprehensive ultrasound approach. Curr Opin Crit Care. 2022 Jun 1;28(3):322-330. doi: 10.1097/MCC.0000000000000941.
PubMed 35653254Galindo Martin CA, Monares Zepeda E, Lescas Mendez OA. Bedside Ultrasound Measurement of Rectus Femoris: A Tutorial for the Nutrition Support Clinician. J Nutr Metab. 2017;2017:2767232. doi: 10.1155/2017/2767232. Epub 2017 Mar 13.
PubMed 28386479Paris MT, Mourtzakis M, Day A, Leung R, Watharkar S, Kozar R, Earthman C, Kuchnia A, Dhaliwal R, Moisey L, Compher C, Martin N, Nicolo M, White T, Roosevelt H, Peterson S, Heyland DK. Validation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient (VALIDUM Study). JPEN J Parenter Enteral Nutr. 2017 Feb;41(2):171-180. doi: 10.1177/0148607116637852. Epub 2016 Jul 11.
PubMed 26962061Pardo E, El Behi H, Boizeau P, Verdonk F, Alberti C, Lescot T. Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients. BMC Anesthesiol. 2018 Dec 27;18(1):205. doi: 10.1186/s12871-018-0647-9.
PubMed 30591032
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TESTO-TRIAL: Randomized Clinical Trial on the Use of Testosterone in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06592144
- Acronym / sponsor ID
- TT / CAAE76790723.5.0000.5440072024
- Conditions
- Weaning Failure, Muscle Weakness, Mechanical Ventilation Complication, ICU Acquired Weakness, Mobility Limitation
- Keywords
- Testosterone, Mechanical ventilation, Weaning, Critical Illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Leticia Maria Defendi Barboza MarsonUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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 objective of this study is to evaluate whether the use of the anabolic agent testosterone cypionate in critically ill patients, compared to placebo, increases the number of ventilator-free days
Detailed description
It will be a randomized, controlled, double-blind, single-center clinical trial conducted in the Intensive Care Unit (ICU) of the State Hospital of Serrana (HE Serrana). Patients admitted to the ICU who meet the eligibility criteria and have given written informed consent will be randomized into control and intervention groups. Forty-seven patients will be included in each group, totaling 94 patients. The intervention group will receive 200 mg of testosterone cypionate intramuscularly every 5 days for a total of 3 doses. The control group will receive a placebo on the same schedule. After inclusion in the study, demographic and clinical data, laboratory results, ultrasonographic measurements, and functionality and muscle strength scores will be assessed on days 1, 5, 10, and 15 in the ICU and until hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group: Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses. Control Group: Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses.
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: Testosterone cypionate (200mg/3ml)Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses. |
| Sesame oil | Placebo comparator | Other: Sesame oil (3ml)Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients on mechanical ventilation (MV) for seven days or more, or patients on MV with an unsuccessful weaning attempt for at least three days. An unsuccessful weaning attempt is defined as the patient undergoing a Spontaneous Breathing Trial (SBT) on three different days without success, according to the ICU protocol;
- Over 18 years old;
- Patients with optimized nutritional therapy, defined by caloric and protein goals met for at least three days;
- Signing the informed consent form (ICF).
Key exclusion criteria (15 listed)
- Hypersensitivity to the medication, the vehicle of the medication, or the placebo (sesame oil);
- Venous or arterial thrombosis in the past six months, including acute myocardial infarction, ischemic stroke, acute arterial occlusion, mesenteric ischemia, venous thromboembolism, or pulmonary embolism;
- Left Ventricular Ejection Fraction (LVEF) below 35%;
- Glutamic-pyruvic transaminase/Alanine Aminotransferase (GPT/ALT) greater than five times the normal level and impaired bilirubin excretion;
- Patients with liver cirrhosis (CHILD > B);
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 cypionate (200mg/3ml)It will be administered intramuscularly every 5 days, totaling 3 doses. | Drug | Testosterone |
| Sesame oil (3ml)It will be administered intramuscularly every 5 days, totaling 3 doses. | Other | Sesame oil |
Primary outcome
Ventilator-free days at 28 days, starting from the date of randomization.
Time frame: 28 days
Evaluate whether the use of the anabolic steroid testosterone cypionate, compared to a placebo, increases the number of ventilator-free days in critically ill patients.
20 secondary outcomes
Length of stay in the hospital, measured in days.
Time frame: ICU and hospital stay, assessed up to 8 weeks.
Length of stay in the ICU, measured in days.
Time frame: ICU and hospital stay, assessed up to 8 weeks.
Ventilator weaning time in days, starting from the date of randomization.
Time frame: ICU stay, assessed up to 8 weeks.
In-hospital mortality from any cause.
Time frame: Hospital stay, assessed up to 8 weeks.
Sequential Organ Failure Assessment (SOFA) score during the ICU stay, starting from the date of randomization.
Time frame: ICU stay, assessed up to 8 weeks.
Diaphragmatic muscle thickness.
Time frame: Hospital stay, assessed up to 8 weeks
Diaphragmatic thickening fraction.
Time frame: Hospital stay, assessed up to 8 weeks
Skeletal muscle assessment: quadriceps thickness.
Time frame: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: Medical Research Council Sum-Score (MRC-SS).
Time frame: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: dynamometry.
Time frame: Hospital stay, assessed up to 8 weeks.
Skeletal muscle assessment: calf circumference.
Time frame: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: ICU Mobility Scale.
Time frame: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: Perme Intensive Care Unit Mobility Score.
Time frame: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: FSS-ICU (Functional Status Score for the Intensive Care Unit).
Time frame: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: TUG (Timed Up and Go).
Time frame: Hospital stay, assessed up to 8 weeks.
Correlation of serum testosterone levels, clinical characteristics, and demographics of patients.
Time frame: Hospital stay, assessed up to 8 weeks.
Correlation with serum levels of hemoglobin and hematocrit, in addition to patients clinical characteristics.
Time frame: Hospital stay, assessed up to 8 weeks.
Correlation with serum albumin levels and patients clinical characteristics.
Time frame: Hospital stay, assessed up to 8 weeks.
Functionality and quality of life of critically ill patients during hospital stay: the Barthel Index.
Time frame: Hospital stay, assessed up to 8 weeks.
Quality of life of critically ill patients during hospital stay: EQ-5D (EuroQol 5-Dimension).
Time frame: Hospital stay, assessed up to 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 32773614Wischmeyer PE, Suman OE, Kozar R, Wolf SE, Molinger J, Pastva AM. Role of anabolic testosterone agents and structured exercise to promote recovery in ICU survivors. Curr Opin Crit Care. 2020 Oct;26(5):508-515. doi: 10.1097/MCC.0000000000000757.
- Background: PubMed 27272101Stanojcic M, Finnerty CC, Jeschke MG. Anabolic and anticatabolic agents in critical care. Curr Opin Crit Care. 2016 Aug;22(4):325-31. doi: 10.1097/MCC.0000000000000330.
- Background: PubMed 35791659Anstey MH, Rauniyar R, Fitzclarence E, Tran N, Osnain E, Mammana B, Jacques A, Palmer RN, Chapman A, Wibrow B. Muscle Growth and Anabolism in Intensive Care Survivors (GAINS) trial: a pilot randomised controlled trial. Acute Crit Care. 2022 Aug;37(3):295-302. doi: 10.4266/acc.2021.01767. Epub 2022 Jun 27.
- Background: PubMed 20592293Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.
- Background: PubMed 29854477Anstey M, Desai S, Torre L, Wibrow B, Seet J, Osnain E. Anabolic Steroid Use for Weight and Strength Gain in Critically Ill Patients: A Case Series and Review of the Literature. Case Rep Crit Care. 2018 May 7;2018:4545623. doi: 10.1155/2018/4545623. eCollection 2018.
- Background: PubMed 26454425Li H, Guo Y, Yang Z, Roy M, Guo Q. The efficacy and safety of oxandrolone treatment for patients with severe burns: A systematic review and meta-analysis. Burns. 2016 Jun;42(4):717-27. doi: 10.1016/j.burns.2015.08.023. Epub 2015 Oct 9.
- Background: PubMed 29558983Dres M, Demoule A. Diaphragm dysfunction during weaning from mechanical ventilation: an underestimated phenomenon with clinical implications. Crit Care. 2018 Mar 20;22(1):73. doi: 10.1186/s13054-018-1992-2.
- Background: PubMed 27620292Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
- Background: PubMed 35395861Haaksma ME, Smit JM, Boussuges A, Demoule A, Dres M, Ferrari G, Formenti P, Goligher EC, Heunks L, Lim EHT, Mokkink LB, Soilemezi E, Shi Z, Umbrello M, Vetrugno L, Vivier E, Xu L, Zambon M, Tuinman PR. EXpert consensus On Diaphragm UltraSonography in the critically ill (EXODUS): a Delphi consensus statement on the measurement of diaphragm ultrasound-derived parameters in a critical care setting. Crit Care. 2022 Apr 8;26(1):99. doi: 10.1186/s13054-022-03975-5.
- Background: PubMed 33237154Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
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- Background: PubMed 28386479Galindo Martin CA, Monares Zepeda E, Lescas Mendez OA. Bedside Ultrasound Measurement of Rectus Femoris: A Tutorial for the Nutrition Support Clinician. J Nutr Metab. 2017;2017:2767232. doi: 10.1155/2017/2767232. Epub 2017 Mar 13.
- Individual participant dataSharing planned: Yes. Anonymous participant data will be available upon completion of clinical trials and publication of the results of the completed study upon request to the corresponding author. Proposals will be reviewed and approved by the sponsor, researcher, and staff on the basis of scientific merit and absence of competing interests. After the proposal has been approved, data can only be shared through a secure online platform after data access code exchange and a confidentiality agreement are signed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone cypionate (200mg/3ml) and Sesame oil (3ml) in people with Weaning Failure and Muscle Weakness, run by Leticia Maria Defendi Barboza Marson 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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days at 28 days, starting from the date of randomization. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06592144, which also lists 14 linked publications.
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 18 Dec 2024.