To hear about similar clinical trials, please enter your email below
Trial Title:
An Acupuncture Study for People At High Risk for Sepsis
NCT ID:
NCT06344819
Condition:
Sepsis
Conditions: Official terms:
Sepsis
Toxemia
Conditions: Keywords:
sepsis
acupuncture
Memorial Sloan Kettering Cancer Center
24-062
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Acupuncture
Description:
Acupuncture involves insertion of thin filiform needles (gauze 30-40) at certain points
on the body.
Arm group label:
Acupuncture
Intervention type:
Other
Intervention name:
Sham Acupuncture
Description:
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.
Arm group label:
Sham Acupuncture
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gary Deng, MD, PhD
Phone:
646-608-8556
Start date:
March 20, 2024
Completion date:
March 20, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06344819
http://www.mskcc.org
