Effects of Oxandrolone on clinical outcomes and muscle mass in patients with Septic shock

Effects of Oxandrolone on clinical outcomes and muscle mass in patients with Septic shock: a randomized clinical trial - ONSET Oxandrolona iN SEpTic patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2hs894w

Enrollment

Unknown

Registered

2023-10-27

Start date

2023-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

Participants will be allocated into two groups through randomization in blocks of 6 patients. Randomization will be carried out by a researcher who will not directly participate in the study. The inte

D04.210.500.054.040.581

Eligibility

Inclusion criteria

Inclusion criteria: Individuals over 18 years of age; of both genders; hospitalized with a diagnosis of septic shock in the Intensive Care Service of the Hospital das Clínicas da Faculdade de Medicina de Botucatu from October 2023 to June 2025

Exclusion criteria

Exclusion criteria: Patients with the following characteristics will be excluded: pregnant women; noradrenaline dose > 2.0µg/Kg/min; patients with non-functioning gastrointestinal tract; diagnosis of brain death; patients with a history of previous use of anabolic steroids; association with other types of shock (cardiogenic, hemorrhagic or hypovolemic); patients with breast or prostate cancer and those who spontaneously refuse to participate in the research

Design outcomes

Primary

Measure	Time frame
To evaluate muscle mass by ultrasound through measurements of muscle thickness obtained by ultrasound and bioimpedance through the evaluation of skeletal muscle mass (MME) and fat-free mass index (FMI) in patients with septic shock who received oxandrolone. The main hypothesis of the study is that the anabolic effects of oxandrolone will attenuate the hypermetabolic response of patients with septic shock, reducing muscle catabolism and loss of lean mass	—

Measure

Time frame

To evaluate muscle mass by ultrasound through measurements of muscle thickness obtained by ultrasound and bioimpedance through the evaluation of skeletal muscle mass (MME) and fat-free mass index (FMI) in patients with septic shock who received oxandrolone. The main hypothesis of the study is that the anabolic effects of oxandrolone will attenuate the hypermetabolic response of patients with septic shock, reducing muscle catabolism and loss of lean mass

—

Secondary

Measure	Time frame
To assess mortality, length of stay, and changes in serum cathepsin B and CAF in patients with septic shock who received oxandrolone. The main hypothesis of the study is that the anabolic effects of oxandrolone will attenuate the hypermetabolic response of patients with septic shock, reducing mortality and altering muscle markers	—

Countries

Brazil

Contacts

Public ContactRaquel Ballarin

Universidade Estadual Paulista Júlio de Mesquita

raquel.ballarin@unesp.br+5514997864806

Outcome results

None listed

Source: REBEC (via WHO ICTRP)