NCT06344819

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_2 sepsis

Timeline
23mo left

Started Mar 2024

Longer than P75 for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2024Mar 2028

Study Start

First participant enrolled

March 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

March 21, 2024

Last Update Submit

May 19, 2026

Conditions

Sepsis

Keywords

sepsisacupunctureMemorial Sloan Kettering Cancer Center24-062

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Sham Acupuncture

SHAM COMPARATOR
Other: Sham Acupuncture

Interventions

AcupuncturePROCEDURE

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

Acupuncture
Sham AcupunctureOTHER

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.

Sham Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Sepsis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Gary Deng, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Deng, MD, PhD

CONTACT

646-608-8556dengg@mskcc.org

Jun Mao, MD, MSCE

CONTACT

646-608-8552maoj@mskcc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 3, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

March 20, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)