PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors

Therapuetic Areas:Other
Age Range:18 - Any
Start Date:January 2015
End Date:July 2019
Contact:Jennifer Lanz, MSN

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Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: Cardiac Dysfunction in Older Sepsis Survivors

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.

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

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.

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

- First entrance into the sepsis protocol at Shands/UF on index admission.

- ability to obtain informed consent.

Exclusion Criteria:

- Expected lifespan of the patients is less than 3 months due to severe pre-existing
comorbidities (ex. recurrent, advanced or metastatic cancer).

- 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)

- Patient or patient's family are not committed to aggressive management of the
patient's condition.

- severe Congestive Heart Failure (CHF) (NY Heart Association Class IV)

- Child-Pugh Class C liver disease 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.

- Chemotherapy or radiotherapy within 30 days prior to sepsis.

- Spinal cord injuries resulting in permanent sensory and/or motor deficits.

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
We found this trial at
Gainesville, Florida 32610
Principal Investigator: Scott Brakenridge, MD
Phone: 352-273-5497
Gainesville, FL
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