Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592144
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
TESTO-TRIAL Use of Testosterone in Critically Ill Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TESTO-TRIAL Randomized Clinical Trial on the Use of Testosterone in Critically Ill Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TT
Brief Summary:
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:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None