An Acupuncture Study for People At High Risk for Sepsis

ConditionSepsis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Having a sepsis order-set placed within the previous 48 hours

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Acupuncture
Procedure/Surgery
Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body.
Sham Acupuncture
Other intervention
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.

Treatment groups

78 Participants

are divided into 2 treatment groups

Group A: AcupunctureExperimental treatment 1 intervention

Group B: Sham AcupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Up to 2 years

Admission/transfer to ICU

Deterioration of a participant's clinical condition that necessitate an admission or transfer to an Intensive Care Unit (ICU)

Time frame

Within 30 days

Secondary outcomes

Mortality

Death within 30 days in the same hospitalization

Time frame

30 days

Other outcomes

Biomarkers

Blood level of catecholamines and pro-inflammatory cytokines

Time frame

From 2 hours before to 2 hours after the first acupuncture treatment

Hospital stays

Number of days in the ICU or the hospital within 30 days during the same hospitalization.

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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