Status:
ACTIVE_NOT_RECRUITING
PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
American Heart Association
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Brief Summary
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 t...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2026
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT02276417
Start Date
January 1 2015
End Date
July 24 2026
Last Update
August 28 2025
Active Locations (1)
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1
UF Health Shands Hospital
Gainesville, Florida, United States, 32610