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Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock

NCT03754257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-10-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Experimental Electrical Stimulation

Experimental Electrical Stimulation (100Hz) during 40 minutes

PROCEDURE

Sham Electrical Stimulation

Sham Electrical Stimulation (5Hz) during 40 minutes

OTHER

Conventional Physiotherapy

Active and passive exercises, and walking.

Sponsors & Collaborators

  • Hospital Sirio-Libanes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2024-10-21
Completion
2024-10-21

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754257 on ClinicalTrials.gov