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TESTO-TRIAL: Use of Testosterone in Critically Ill Patients

NCT ID: NCT06592144

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2026-11-02

Brief Summary

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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

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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

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Weaning Failure Muscle Weakness Mechanical Ventilation Complication ICU Acquired Weakness Mobility Limitation

Keywords

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Testosterone Mechanical ventilation Weaning Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
All assistant team members (physicians, pharmacists, nurses, etc.) and statisticians responsible for the analyses will remain blind to the identity of the treatments throughout the study.

The placebo (sesame oil) will be prepared in a similar packaging and with a volume identical to that of testosterone cypionate.

If a patient experiences an adverse effect potentially related to the medication, the attending physician may request to break the study blinding.

Study Groups

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Testosterone

Participants will receive 200 mg of testosterone cypionate intramuscularly every 5 days, up to a maximum of 3 doses.

Group Type EXPERIMENTAL

Testosterone cypionate (200mg/3ml)

Intervention Type DRUG

It will be administered intramuscularly every 5 days, totaling 3 doses.

Sesame oil

Participants will receive sesame oil (placebo) intramuscularly every 5 days, up to a maximum of 3 doses.

Group Type PLACEBO_COMPARATOR

Sesame oil (3ml)

Intervention Type OTHER

It will be administered intramuscularly every 5 days, totaling 3 doses.

Interventions

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Testosterone cypionate (200mg/3ml)

It will be administered intramuscularly every 5 days, totaling 3 doses.

Intervention Type DRUG

Sesame oil (3ml)

It will be administered intramuscularly every 5 days, totaling 3 doses.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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;
* 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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leticia Maria Defendi Barboza Marson

OTHER

Sponsor Role lead

Responsible Party

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Leticia Maria Defendi Barboza Marson

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Estadual Serrana

Serrana, SP/Brazil, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 32773614 (View on PubMed)

Stanojcic 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.

Reference Type BACKGROUND
PMID: 27272101 (View on PubMed)

Anstey 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.

Reference Type BACKGROUND
PMID: 35791659 (View on PubMed)

Basaria 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.

Reference Type BACKGROUND
PMID: 20592293 (View on PubMed)

Anstey 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.

Reference Type BACKGROUND
PMID: 29854477 (View on PubMed)

Li 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.

Reference Type BACKGROUND
PMID: 26454425 (View on PubMed)

Dres 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.

Reference Type BACKGROUND
PMID: 29558983 (View on PubMed)

Zambon 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.

Reference Type BACKGROUND
PMID: 27620292 (View on PubMed)

Haaksma 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.

Reference Type BACKGROUND
PMID: 35395861 (View on PubMed)

Santana 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.

Reference Type BACKGROUND
PMID: 33237154 (View on PubMed)

Santangelo 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.

Reference Type BACKGROUND
PMID: 35653254 (View on PubMed)

Galindo 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.

Reference Type BACKGROUND
PMID: 28386479 (View on PubMed)

Paris 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.

Reference Type BACKGROUND
PMID: 26962061 (View on PubMed)

Pardo 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.

Reference Type BACKGROUND
PMID: 30591032 (View on PubMed)

Other Identifiers

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CAAE76790723.5.0000.5440072024

Identifier Type: -

Identifier Source: org_study_id