An Acupuncture Study for People At High Risk for Sepsis

Sepsis Clinical Trial

Official title:

Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344819
• Other study ID #: 24-062
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: March 20, 2028

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Gary Deng, MD, PhD
• Phone: 646-608-8556
• Email: dengg[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 20, 2028
• Est. primary completion date: March 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center