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

April 13, 2023 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Sub-Investigator:
          • Bertrand SOUWEINE
        • Principal Investigator:
          • Konstantinos BACHOUMAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 4 to day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 4 to day 14
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
day 4 to day 14
Nitrogen balance
Time Frame: daily from day 1 to day 14
Daily and cumulative nitrogen balance from day 1 to extubation
daily from day 1 to day 14
Physical performance
Time Frame: day 14, 1month and 3 months after ICU discharge
Physical performance by Six-minute walk test (6MWT)
day 14, 1month and 3 months after ICU discharge
Muscle strength
Time Frame: at ICU discharge, 1month and 3 months after ICU discharge
Muscle strength by MRC (Medical Research Scale)
at ICU discharge, 1month and 3 months after ICU discharge
Near Infrared Spectroscopy
Time Frame: at 14 days
Near Infrared Spectroscopy by NIRS test
at 14 days
Muscular mass
Time Frame: at ICU discharge and 1month after ICU discharge
Muscular mass by L3 computed tomography
at ICU discharge and 1month after ICU discharge
Lung function
Time Frame: at 1 and 3 months after ICU discharge
Lung function by spirometry
at 1 and 3 months after ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Konstantinos BACHOUMAS, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-404
  • 2017-004978-34 (Other Identifier: 2017-004978-34)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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