PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors
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About
The purpose of this study is to define the natural history and causes of chronic critical illness (CCI) in surgical intensive care patients who have had sepsis. The investigator also wants to define the long-term physical and cognitive outcomes of this disease. The investigator will be looking at many clinical variables to try to define CCI.
Full description
This is a prospective, observational study aimed at identifying the frequency, natural history and long term outcomes of CCI and PICS in the survivors of surgical or trauma-associated sepsis.
A major portion of the translational data to be obtained will be from urine and blood samples from septic patients identified in the surgery and trauma ICUs. The blood will be processed for genomic markers, inflammatory markers, immunosuppression markers, Myeloid Derived Suppressor Cells (MDSC) functions, and angiogenic factors. The urine will be processed for messenger RNA (mRNA) isolation and protein biomarkers.
Bioimpedance analysis will performed to assess body composition. In order to assess the long term outcomes, the following Quality-of-life, functional and cognitive tests will be performed.
Health-related quality of life questionnaire, EuroQol-5D, Mini Nutritional Assessment Form, the Hopkins Verbal Learning Test, Controlled Oral Word Association, Modified Mini-Mental Status Exam, Short PhysicalPerformance Battery, Hand Grip Strength Measurement and The Eastern Cooperative Oncology Group (ECOG), World Health Organization (WHO), Zubrod Scale Healthy volunteer subjects will be identified from the general population. Healthy subjects will be screened via inclusion/exclusion criteria upon contact. If appropriate for participation, the subject will be consulted for consent.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- presence in the surgery or trauma intensive care unit (ICU) at University of Florida (UF) Health Shands Hospital where clinical care can be managed by surgical critical care guided by standard operating procedures.
- age of ≥18 years
- placed on EMR sepsis protocol with sepsis/septic shock by Sepsis-3 criteriad
- ability to obtain informed consent.
Exclusion criteria
- patients deemed to be futile care or have advanced care directives or goals of care limiting resuscitative efforts.
- severe traumatic brain injury (evidence of neurologic injury on CT scan and a Glasgow Coma Scale (GCS) <8 after resuscitation).
- refractory shock (i.e., patients who die within 12 hours).
- uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
- severe Congestive Heart Failure (CHF) (NY Heart Association Class IV)
- severe chronic liver disease (Childs-Pugh Class B/C and /or MELD > 14) or pre-liver transplant.
- known HIV infection with CD4 count <200 cells/mm3
- organ transplant recipient on immunosuppressive agents
- known pregnancy
- prisoners
- institutionalized patients
- inability to obtain informed consent.
- pre-hospital bedridden status (WHO/Zubrod score ≥ 4).
- patient's with an exacerbation of historic CVD or new onset CVD
- alternative or confounding diagnosis causing shock state (e.g. MI or PE)
- enrollment > 96 hours after suspected sepsis onset.
- pre-existing state of Chronic critical illness (ICU LOS ≥ 14 days, includes outside facility)
- interfacility transfer patients with > 96 hour critical illness prior to transfer.
- subsequent clinical adjudication not consistent with sepsis/septic shock by Sepsis-3 criteria
Healthy Controls
Inclusion criteria will be:
- all adults (age ≥18)
- Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria will be:
- Current, chronic steroid use
- Pregnancy
Trial design
668 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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