An Acupuncture Study for People At High Risk for Sepsis

NCT06344819 | Recruiting Phase 2

• 2 other identifiers: STUDY00000011R21CA286330
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture.

Conditions

Sepsis

Keywords

sepsis; acupuncture

Outcome Measures

Primary Outcomes (2)

• Number of participants recruited compared to the number of participants who complete study treatment.

  To assess the feasibility of conducting a randomized controlled trial of acupuncture in hospitalized patients who are at risk for sepsis.

  Up to 2 years

• Admission/transfer to ICU

  Deterioration of a participant's clinical condition that necessitate an admission or transfer to an Intensive Care Unit (ICU)

  Within 30 days

Secondary Outcomes (1)

• Mortality

  30 days

Other Outcomes (2)

• Biomarkers

  From 2 hours before to 2 hours after the first acupuncture treatment

• Hospital stays

  30 days

Study Arms (2)

Acupuncture

EXPERIMENTAL

Procedure: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Other: Sham Acupuncture

Interventions

Acupuncture PROCEDURE

Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body.

Acupuncture

Sham Acupuncture OTHER

During sham acupuncture, a point on the participant's ankle is gently tapped with an acupuncture needle guide tube and an acupuncture needle is taped flat to the skin. This point is not on any acupuncture meridian or point. Electrical stimulation device is connected to the needles, but no electrical stimulation is delivered.

Sham Acupuncture

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Having a sepsis order-set placed within the previous 48 hours

You may not qualify if:

• The study Principal Investigator will review the medical record again prior to enrollment to exclude non-sepsis patients (Even though the placement of sepsis order set already screens out such patients, subsequent clinical development after sepsis order set placement may generate new information that deems the patient not septic.)
• Admitted to ICU before being approached for consenting
• Having an implanted medical device, such as a pacemaker or implantable cardioverter-defibrillator (ICD), with which electroacupuncture
• Unable to obtain informed consent due to a participant's mental status and absence of an individual authorized to give consent on the participant's behalf
• The patient is on an interventional clinical trial and its Principal Investigator does not give approval to enrollment to this study (e.g. genomic profiling, biospecimen, or observational studies do not require PI approval).

Sponsors & Collaborators

• University of California, Irvine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Susan Samueli Integrative Health Institute, University of California, Irvine

Irvine, California, 92617, United States

RECRUITING

Related Links

• University of California Irvine, clinical trials

MeSH Terms

Conditions

Sepsis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gary Deng, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Deng, MD, PhD

CONTACT

949-824-7000; garyd2@hs.uci.edu

Georgia Christodoulou, PhD

CONTACT

gchrist3@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient's inpatient clinical care team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: RCT of true vs sham acupuncture

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (1)