This phase II trial tests the feasibility and how well acupuncture works to improve outcomes for patients who are at risk for sepsis. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. Sepsis is a life-threatening inflammatory condition caused by the body’s response to infection. Receiving acupuncture may improve patient outcomes.
Additional locations may be listed on ClinicalTrials.gov for NCT06344819.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Gary E. Deng
Phone: 646-608-8556
PRIMARY OBJECTIVE:
I. To assess the feasibility (in terms of participant recruitment, participant attrition/retention, and intervention delivery rate) of conducting a randomized controlled trial of acupuncture in hospitalized patients who are at risk for sepsis.
SECONDARY OBJECTIVE:
I. To generate preliminary data for the estimated effect size among sepsis patients of acupuncture in reducing mortality and intensive care unit (ICU) admissions (two separate endpoints) during the same hospitalization within 30 days of enrollment.
EXPLORATORY OBJECTIVE:
I. To explore whether true acupuncture increases catecholamines and reduces inflammatory cytokines more than sham acupuncture in samples taken before and 2-hours after the first acupuncture treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo electro-acupuncture once per day, for up to 10 days in the absence of discharge or transfer to the intensive care unit (ICU). Patients undergo blood sample collection throughout the study.
ARM II: Patients undergo sham acupuncture once per day, for up to 10 days in the absence of discharge or transfer to the ICU. Patients undergo blood sample collection throughout the study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorGary E. Deng
