An Acupuncture Study for People At High Risk for Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Sham Acupuncture.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial
Overview
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.
Interventions
- Procedure Acupuncture
Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body. - 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.
Primary outcome measures
- Number of participants recruited compared to the number of participants who complete study treatment. [Time frame: Up to 2 years]
- Admission/transfer to ICU [Time frame: Within 30 days]
Secondary outcome measures (1)
- Mortality [Time frame: 30 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Susan Samueli Integrative Health Institute, University of California, Irvine — Irvine
Identifiers
NCT: NCT06344819 · STUDY00000011 · R21CA286330