An Acupuncture Study for People At High Risk for Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2028-03-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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

Sham Acupuncture

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

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.

Interventions

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Acupuncture

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No