Health TrialsbyHealthPanel

Assessing Immune Dysfunction in Sepsis

ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18

Presumed diagnosis of sepsis, defined as "patients with life-threatening organ dysfunction caused by a dysregulated host response to infection"

Respiration rate ≥ 22 breaths/min and/or mechanically ventilated

An alteration in mental status

Disqualifiers

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.

Trial population

Patients with and without sepsis in the ICU, compared to healthy volunteers

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observational Only

    Other intervention

    No intervention is included in this study

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: ICU Patients with Sepsis1 intervention
Group B: ICU Patients without Sepsis1 intervention
Group C: Healthy Volunteers1 intervention

Trial outcomes

Primary outcomes

1

EliSpot - Day 1

Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

Time frame
Day 1
2

EliSpot - Day 4

Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

Time frame
Day 4
3

EliSpot - Day 7

Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

Time frame
Day 7
4

EliSpot - Day 14

Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

Time frame
Day 14

Secondary outcomes

Other outcomes

Sponsors and contacts

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

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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