Sepsis
Conditions
Keywords
sepsis, acupuncture
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.
Interventions
PROCEDUREAcupuncture
Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points on the body.
OTHERSham 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.
Sponsors
University of California, Irvine
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patient's inpatient clinical care team.
Intervention model description
RCT of true vs sham acupuncture
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recruited compared to the number of participants who complete study treatment. | 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. |
| Admission/transfer to ICU | Within 30 days | Deterioration of a participant's clinical condition that necessitate an admission or transfer to an Intensive Care Unit (ICU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Death within 30 days in the same hospitalization |
Countries
United States
Contacts
CONTACTGary Deng, MD, PhD
CONTACTGeorgia Christodoulou, PhD
PRINCIPAL_INVESTIGATORGary Deng, MD, PhD
University of California, Irvine
Outcome results
None listed