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NCT Number: NCT06344819

An Acupuncture Study for People At High Risk for Sepsis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Susan Samueli Integrative Health Institute, University of California, Irvine

Irvine, California, 92617, United States

Location status: Recruiting

Location contact

Gary Deng, MD, PhD

CONTACT

[email protected]

949-824-7000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Acupuncture

Procedure

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

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.

Primary outcomes

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

    Time frame: Up to 2 years

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

  2. Admission/transfer to ICU

    Time frame: Within 30 days

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

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    Death within 30 days in the same hospitalization

Other outcomes

  1. Biomarkers

    Time frame: From 2 hours before to 2 hours after the first acupuncture treatment

    Blood level of catecholamines and pro-inflammatory cytokines

  2. Hospital stays

    Time frame: 30 days

    Number of days in the ICU or the hospital within 30 days during the same hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Gary Deng, MD, PhD

CONTACT

[email protected]

949-824-7000

Georgia Christodoulou, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial

Acronym: ACTIONS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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