An Acupuncture Study for People At High Risk for Sepsis

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: Jun Mao, MD, MSCE; Phone Number: 646-608-8552; Email: maoj@mskcc.org
• Study Contact Backup: Name: Gary Deng, MD, PhD; Phone Number: 646-608-8556; Email: dengg@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Gary Deng, MD, PhD; Phone Number: 646-608-8556

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18 or older
• Having MSK sepsis order-set placed within the previous 24 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 a clinical trial and its Principal Investigator does not give approval to enrollment to this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Acupuncture	Other: Sham Acupuncture; During sham acupuncture, the point on the participant's thigh 6 inches proximal to the ST36 acupuncture point 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.
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Gary Deng, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

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): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; sepsis; Memorial Sloan Kettering Cancer Center; 24-062
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 24-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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