An Acupuncture Study for People At High Risk for Sepsis (ACTIONS)

Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Procedure: Acupuncture; Other: Sham Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gary Deng, MD, PhD; Phone Number: 949-824-7000; Email: garyd2@hs.uci.edu
• Study Contact Backup: Name: Georgia Christodoulou, PhD; Email: gchrist3@hs.uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • Recruiting
      • Susan Samueli Integrative Health Institute, University of California, Irvine
      • Contact: Gary Deng, MD, PhD; Phone Number: 949-824-7000; Email: garyd2@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Acupuncture	Other: 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.
Experimental: Acupuncture	Procedure: Acupuncture; Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death within 30 days in the same hospitalization	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Blood level of catecholamines and pro-inflammatory cytokines	From 2 hours before to 2 hours after the first acupuncture treatment
Hospital stays	Number of days in the ICU or the hospital within 30 days during the same hospitalization.	30 days

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gary Deng, MD, PhD, University of California, Irvine

Publications and helpful links

Helpful Links

• University of California Irvine, clinical trials

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: STUDY00000011; R21CA286330 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No