Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

NCT ID: NCT06990295

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2026-07-02

Brief Summary

This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition characterized by excessive inflammation and organ dysfunction. The primary objective is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce circulating inflammatory cytokine levels in this patient population.

Eligibility Criteria:

Adults aged 18 years or older Diagnosed with septic shock and admitted to the ICU within 24 hours Expected to require intensive care for at least 72 hours

Study Protocol:

Participants will be randomly assigned to one of two groups:

Intervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device.

Control Group: Will receive standard septic shock care alone. Blood samples will be collected at baseline, Day 3, and Day 5 to measure inflammatory cytokine levels, including TNF-α, IL-1β, IL-6, and IL-10. Additional assessments will include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and adverse events.

Outcome Measures:

Primary: Change in levels of inflammatory cytokines on Day 3 and Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.

Detailed Description

This randomized, controlled pilot study investigates the safety and efficacy of focused ultrasound neuromodulation of the spleen in adult patients diagnosed with septic shock. Participants will be randomized into two groups: one receiving standard of care and the other receiving additional targeted spleen stimulation via focused ultrasound. The intervention involves twice-daily sessions over five days, utilizing a portable device designed to deliver precise, non-invasive ultrasound energy to the splenic region. The rationale for targeting the spleen stems from its role in immunomodulation, particularly in the regulation of inflammatory cytokines involved in septic shock pathophysiology.

Blood samples will be systematically collected at baseline, Day 3, and Day 5 to quantify serum levels of key inflammatory cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), and interleukin-10 (IL-10), using validated immunoassays. In addition, lymphocyte subpopulations will be analyzed via flow cytometry to assess immune cell dynamics. Organ dysfunction will be evaluated using the Sequential Organ Failure Assessment (SOFA) score at specified time points to monitor changes in organ status. Data on ICU length of stay and 28-day mortality will be collected to evaluate clinical outcomes. Adverse events related to the intervention will be documented to assess safety and tolerability.

By investigating the immunomodulatory effects of focused ultrasound spleen neuromodulation, this study aims to establish preliminary safety and efficacy data for a potentially transformative therapeutic modality in septic shock management.

Conditions

Septic Shock; Inflammatory Cytokines; Spleen Neuromodulation; Focused Ultrasound; Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Focused Ultrasound Spleen Neuromodulation Group

Patients receive standard septic shock care plus twice-daily non-invasive focused ultrasound stimulation over the spleen for five consecutive days, using a portable ultrasound neuromodulation device.

Group Type: EXPERIMENTAL

Focused Ultrasound Spleen Neuromodulation

Intervention Type: PROCEDURE

A portable focused ultrasound device is used to stimulate the spleen area under real-time imaging guidance. Each session lasts approximately 20 minutes, repeated twice daily for five days.

Control Group

Patients receive standard care for septic shock according to current clinical guidelines, without focused ultrasound spleen stimulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Focused Ultrasound Spleen Neuromodulation

A portable focused ultrasound device is used to stimulate the spleen area under real-time imaging guidance. Each session lasts approximately 20 minutes, repeated twice daily for five days.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years, regardless of sex
• Diagnosed with septic shock according to Sepsis-3 criteria: Sequential Organ Failure Assessment (SOFA) score ≥ 2 and requiring vasopressor support to maintain a mean arterial pressure (MAP) ≥ 65 mmHg.
• Admitted to the ICU within 24 hours of septic shock diagnosis
• Expected to require intensive care for at least 72 hours
• Informed consent obtained from the patient or legal representative

Exclusion Criteria

• Known pregnancy or breastfeeding
• Participation in another interventional clinical trial within 30 days
• Known immunodeficiency or ongoing immunosuppressive therapy
• Malignancy with life expectancy < 6 months
• Contraindications to focused ultrasound (e.g., splenic trauma, splenectomy, local skin infection)
• Do-not-resuscitate (DNR) order or expected death within 24 hours
• Any other condition deemed unsuitable for participation by the investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhu City Second People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qiancheng Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qiancheng Xu

Role: CONTACT

qianchengxu@wnmc.edu.cn

86-18297529106

Other Identifiers

202580

Identifier Type: -

Identifier Source: org_study_id