Testosterone gel fails to normalize serum levels in critically ill ICU patients in pilot RCT

BACKGROUND: Critical illness is associated with hypercatabolism, systemic inflammatory dysregulation and low serum concentration of testosterone (T) leading to intensive care unit (ICU) acquired weakness and altered outcome. T supplementation benefit has been reported in several illnesses but data in non-burned ICU patients are scarce. In this context, the purpose of the TestICUs-1 study was to assess the pharmacokinetic and safety of T-gel administration in ICU patients. METHODS: TestICUs-1 was an open, monocentric, randomized controlled study carried out in ICU patients receiving vasopressors, and mechanical ventilation for at least two days. Exclusion criteria included prostate or breast cancer, PSA levels >4 ng/mL and age ≥ 80 years. The T group received a 14-day administration of T transdermal gel (Androgel©). The primary endpoint was the percentage of patients with serum Total T value within normal ranges on days 4, 7, 10 and 14. The safety of T-gel was also assessed. RESULTS: 30 patients were included, 19 (63 %) were men. At inclusion, none of the men and half of the women presented a serum Total T values within normal range. On days 4, 7, 10 and 14, the percentage of patients with a normal serum Total T value did not differ between T administered patients and controls. No significant differences between groups were reported in terms of cardiovascular events and cytolysis. CONCLUSIONS: The administration of T-gel did not increase significantly the percentage of patients with normal serum T values as compared to control.