Recruiting

Phase 2

AcupunctureAn Acupuncture Study for People At High Risk for Sepsis

Sponsor:

UCLA

Code:

NCT06344819

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Sham Acupuncture

Study Details

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

Study ID

NCT06344819

Start date

Mar 20, 2024

Status verified date

Jul, 2026

Completion date

Mar 20, 2028

Anticipated

Primary completion date

Mar 20, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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).

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acupuncture

sham comparator: Sham Acupuncture

Interventions

Acupuncture

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

Sham Acupuncture

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.

Primary outcome measure

Number of participants recruited compared to the number of participants who complete study treatment. [ Time Frame: Up to 2 years ]
Admission/transfer to ICU [ Time Frame: Within 30 days ]

Central Contacts and Locations

Central contacts

Gary Deng, MD, PhD

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

Georgia Christodoulou, PhD

gchrist3@hs.uci.edu

Locations

Susan Samueli Integrative Health Institute, University of California, Irvine

Recruiting

Irvine, California, United States, 92617

Contacts

Gary Deng, MD, PhD

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

More Information

Sponsor

University of California, Irvine

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

sepsis
acupuncture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-07-21.