NCT03678233: TestICUs

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

Status unknown Phase 2 Last updated 18 April 2023

What this trial tests

Phase 2 trial testing AndroGel 16.2 mg/L in Hypermetabolism in ICU in 30 participants. Status unknown.

Timeline

27 June 2019

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	27 June 2019
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across France

Drugs / interventions tested

• AndroGel 16.2 mg/L — full drug profile →

Conditions studied

• Hypermetabolism in ICU — all drugs for Hypermetabolism in ICU →
• Loss of Muscle Mass — all drugs for Loss of Muscle Mass →
• Functional Disability After ICU — all drugs for Functional Disability After ICU →
• ICU Acquired Hypogonadism — all drugs for ICU Acquired Hypogonadism →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

Adults 18 to 79, any sex, with Hypermetabolism in ICU or Loss of Muscle Mass. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hydrogels in the clinic: An update.
   Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680