Status:
ACTIVE_NOT_RECRUITING
Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
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 wants to study a sub-p...
Detailed Description
This is a prospective study aimed at identifying the frequency, natural history and long term outcomes of CCI and PICS in the survivors of Intra-abdominal sepsis. In addition to the in-hospital clini...
Eligibility Criteria
Inclusion
- Admission to the surgery or trauma ICU where clinical care can be managed by surgical critical care guided by standard operating procedures.
- Age ≥18 years
- Diagnosis of sepsis, severe sepsis, or septic shock
- Entrance into the standard-of-care sepsis protocol
- Ability to obtain patient/legally authorized representative informed consent.
Exclusion
- Significant traumatic brain injury (evidence of neurologic injury on CT scan and a best Glascow Coma Scale \<8 within 24 hours of injury)
- Refractory shock (i.e., patients who die within 12 hours)
- Alternative or confounding diagnosis causing shock state (e.g., myocardial infarction or pulmonary embolus)
- Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
- Patients deemed to be futile care or have advanced care directives limiting resuscitative efforts such as patient or patient's family who are not committed to aggressive management of the patient's condition. Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. Recurrent, advanced or metastatic cancer).
- Severe Congestive Heart Failure (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
- Inability to obtain informed consent
- Prisoners
- Institutionalized patients
- Chemotherapy or radiotherapy within 30 days prior to sepsis
- Spinal cord injuries resulting in permanent sensory and/or motor deficits.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02711709
Start Date
April 1 2016
End Date
December 31 2025
Last Update
March 27 2025
Active Locations (1)
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1
UF Health at Shands hospital
Gainesville, Florida, United States, 32610