Assessing Immune Dysfunction in Sepsis

University of Minnesota1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2026年3月1日最近更新: 2026年9月23日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: University of Minnesota
入组人数: 150
试验地点: 1
主要终点: EliSpot - Day 1

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Sepsis leads to sustained immune system dysfunction resulting in increased susceptibility to secondary infection while in the hospital or after discharge. Consequently, many of the ~2 million Americans that develop sepsis every year will end up back in the ICU, weeks and months later. The objective of this study is to define the cellular and molecular mechanisms driving the dysfunction and reprogramming of T cells and B cells that mediate cellular and humoral immunity using a combination of phenotypic, functional, genomic, and metabolomic assays.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•ICU With Sepsis Inclusion Criteria:
•Presumed diagnosis of sepsis, defined as "patients with life-threatening organ dysfunction caused by a dysregulated host response to infection"
•Patients in the ICU who meet 2 or more of the quick SOFA (qSOFA) definition along with organ dysfunction:
•Respiration rate ≥ 22 breaths/min and/or mechanically ventilated
•An alteration in mental status
•Systolic blood pressure of less than 100 mm Hg and/or receiving inotropes to maintain blood pressure AND/OR
•An acute change in SOFA score ≥2 points, consequent to the infection (can assume SOFA score = 0 in patients with no pre-existing organ dysfunction)
•ICU Without Sepsis Inclusion Criteria:
•Patients requiring care at a M Health Fairview ICU due to high acuity of illness and no other evidence of sepsis
•Healthy Volunteer Inclusion Criteria
•Age greater or equal to 18
•ASA status 1, 2 or 3
•May include patients who are receiving dialysis in an outpatient setting

排除标准

•(all groups):
•Active cancer with chemotherapy and/or radiation treatment within the past 6 weeks
•Medication usage that includes immunosuppressive drugs, biologic agents, cytokines, growth factor and interleukins
•Steroid medication usage of > 300mg hydrocortisone per day (equivalent of > 20mg prednisone). Patients with chronic steroid use will be excluded, however patients who have had stress dose steroids administered following admission will be included.
•Patients with a history of, or who currently have evidence of autoimmune disease, including but not limited to: myasthenia gravis, Guillain Barré syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's granulomatosis, HIV/AIDS, etc.
•Patients with active or a history of acute or chronic lymphocytic leukemia
•Known history of chronic hepatitis B (HBV) infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization, or HBV DNA > 100 IU/mL
•Known history of infection with hepatitis C (HCV) and currently undergoing treatment for HCV infection or has detectable HCV RNA
•Participation in another investigational interventional drug study within the past 4 weeks
•Current pregnancy
•Current incarceration

研究组 & 干预措施

ICU Patients with Sepsis

干预措施: Observational Only (Other)

ICU Patients without Sepsis

干预措施: Observational Only (Other)

Healthy Volunteers

干预措施: Observational Only (Other)