Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty

Completed

Conditions studied: Sepsis

In brief

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-population of sepsis patients that have intra-abdominal sepsis. The purpose of this research study is to define the acute changes in frailty (weakness, slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and performing routine daily functions) after having an infection that is located in the abdominal cavity or torso. The investigator believes having severe infection contributes to acute and permanent changes in these areas, especially in those of advanced age.

Key facts

Study ID

NCT02711709

Run by

University of Florida

People needed

53

Starts

2016-04-01

Expected to finish

2026-02-11

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UF Health at Shands hospital — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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