An Acupuncture Study for People At High Risk for Sepsis
Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
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
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or older
- Having MSK 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: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Sham Comparator: 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
|
Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Gary Deng, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 24-062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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