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Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients (TestICUs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678233
Recruitment Status : Unknown
Verified February 2019 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:

Critically ill patients experience major insults that lead to increased protein catabolism. Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage. During acute phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid release. Under stress conditions, protein synthesis cannot match the increased rate of muscle proteolysis because of a state of anabolism resistance, which limits uptake of amino acids into muscles. Hypermetabolism results in a significant loss of lean body mass with an impact on weaning from the ventilator and muscle recovery. Functional disability may be long term sometimes with no full return to normal.

In critically ill patients, severe and persistent testosterone deficiency is very common and is observed early after ICU admission. This acquired hypogonadism promotes the persistent loss of skeletal muscle protein and is related to poor outcome.

Administration of testosterone induces skeletal muscle fiber hypertrophy, decreases protein breakdown in healthy young men and burned patients. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in young and older hypogonadal men and women and can improve physical performance.


Condition or disease Intervention/treatment Phase
Hypermetabolism in ICU Loss of Muscle Mass Functional Disability After ICU ICU Acquired Hypogonadism Treatment With Testosterone Gel in ICU Drug: AndroGel 16.2 mg/L Phase 2

Detailed Description:

Type of trial

TestICUs-1 is a single center open-label parallel randomized controlled study phase II assessing the efficacy of testosterone gel to correct low testosterone serum levels associated with ICU acquired hypogonadism in mechanically ventilated patients with shock. TestICUs-1 will be conducted in the 10-bed medical ICU of the university hospital of Clermont-Ferrand. Study drug is Androgel® 1.62 mg/L approved by the ANSM for the treatment of hypogonadism in men containing 1.62% of testosterone.

Category of research Research involving human subjects aimed at assessing the efficacy of and safety to drug.

Study phase

  • II/ Feasibility
  • Technology Readiness Level : 7 B

A study assessing the efficacy of a multimodal strategy including treatment with testosterone gel, (75 mg/day in men and 25 mg/day in women) in improving physical activity in hemodialysis patients is in progress (Americano PHRC N 2012, AE Heng).

Study Design
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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: Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention
AndroGel® AndroGel 16.2 mg/L will be applied to upper arms or shoulders once a day at 9:00 am to dry and intact skin for a period of 28 days or until ICU discharge. The daily dose 101.25 mg in men and 20.25 mg in women
 Drug: AndroGel 16.2 mg/L
Testosterone gel 1.62 % will be applied to upper arms or shoulders once a day at 9:00 am to dry and intact skin for a period of 28 days or until ICU discharge. The daily dose 101.25 mg in men and 20.25 mg in women.
No Intervention: Control
In the control group, AndroGel will not be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Pourcentage of patients with normal median value of serum total testosterone [ Time Frame: day 4 to day 14 ]
    Pourcentage of patients with median value of serum total testosterone collected from blood samples at day 4, 7, 10, 14 higher than 280 ng/dl in men and 12 ng/dl in women.


Secondary Outcome Measures :
  1. Proportion of patients with normal median free testosterone serum values [ Time Frame: day 4 to day 14 ]
    Proportion of patients with median free testosterone serum values at day 4, 7, 10, 14 higher than 58 pg/ml in men and 0,9 ng/ml in women

  2. Proportion of patients with normal median serum values of bioavailable testosterone [ Time Frame: day 4 to day 14 ]
    Proportion of patients with median serum values of bioavailable testosterone at day 4, 7, 10, 14 higher than 75 ng/dl in men 0.8 ng/dl in women

  3. Nitrogen balance [ Time Frame: daily from day 1 to day 14 ]
    Daily and cumulative nitrogen balance from day 1 to extubation

  4. Physical performance [ Time Frame: day 14, 1month and 3 months after ICU discharge ]
    Physical performance by Six-minute walk test (6MWT)

  5. Muscle strength [ Time Frame: at ICU discharge, 1month and 3 months after ICU discharge ]
    Muscle strength by MRC (Medical Research Scale)

  6. Near Infrared Spectroscopy [ Time Frame: at 14 days ]
    Near Infrared Spectroscopy by NIRS test

  7. Muscular mass [ Time Frame: at ICU discharge and 1month after ICU discharge ]
    Muscular mass by L3 computed tomography

  8. Lung function [ Time Frame: at 1 and 3 months after ICU discharge ]
    Lung function by spirometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Males and females aged over 18 years receiving invasive mechanical ventilation
  • Invasive mechanical ventilation expected to be required for more than 48 hours
  • Treatment with vasoactive drugs
  • Written informed consent obtained from the legal representative
  • Social security cover

Exclusion Criteria:

  • - History of prostate or breast cancer, prostatic specific antigen (PSA) ≥ 4 ng/ml
  • ICU length of stay > 72 h before enrollment
  • Moribund defined as having a score SAPS II > 75 12 hours after admission
  • Pre-existing illness with a life expectancy of <6 months
  • Cardiac arrest
  • Preexistent cognitive impairment or language barrier
  • Acute intracranial or spinal cord injury
  • Acute hemorrhagic or ischemic stroke
  • Neuromuscular disease (Guillain-Barré, myasthenia)
  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not excluded)
  • Documented allergy to testosterone
  • Age > 80 years
  • Pregnancy or breast feeding
  • Patient on judicial protection
Contacts and Locations
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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): NCT03678233


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Konstantinos BACHOUMAS         
Sub-Investigator: Bertrand SOUWEINE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Konstantinos BACHOUMAS University Hospital, Clermont-Ferrand
More Information
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Publications:

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03678233    
Other Study ID Numbers: CHU-404
2017-004978-34 ( Other Identifier: 2017-004978-34 )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
hypermetabolism
hypogonadism
testosterone
Additional relevant MeSH terms:
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Hypogonadism
Critical Illness
Disease Attributes
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
 Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs