Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

NCT06990295 | Not Yet Recruiting

• 1 other identifier: 202580
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Septic Shock; Focused Ultrasound; Spleen Neuromodulation; Inflammatory Cytokines; Critical Care; Immune Modulation; Pilot Study

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Cytokine Levels

  Change in plasma levels of key inflammatory cytokines (e.g., TNF-α, IL-1β, IL-6, IL-10) from baseline to Day 3 and Day 5 after randomization.

  Baseline, Day 3, and Day 5

Secondary Outcomes (4)

• Change in Lymphocyte Subpopulations

  Baseline, Day 3, and Day 5

• Change in Organ Function (SOFA Score)

  Baseline and Day 5

• ICU Length of Stay (LOS)

  Through study completion (anticipated average 14 days)

• 28-day mortality rate

  28 days

Study Arms (2)

Focused Ultrasound Spleen Neuromodulation Group

EXPERIMENTAL

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.

Procedure: Focused Ultrasound Spleen Neuromodulation

Control Group

NO INTERVENTION

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

Interventions

Focused Ultrasound Spleen Neuromodulation 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.

Focused Ultrasound Spleen Neuromodulation Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Wuhu City Second People's Hospital: collaborator

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share