Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT03754257
Brief Summary:
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
Detailed Description:
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Study:
NCT03754257
Study Brief:
Protocol Section:
NCT03754257