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

NCT02711709 | Completed

• 2 other identifiers: IRB201501027-NP30AG028740
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Sepsis

Keywords

Intra-abdominal sepsis; Surgical ICU

Outcome Measures

Primary Outcomes (2)

• A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Fried Frailty Criteria.

  1\. Fried Frailty Criteria: Possible score of 0-5 based on clinical criteria. Score of 0 = "Not Frail", Score of 1-2 = "pre-frail", score ≥3 = "Frail". Integer score, no units of measures

  Baseline, 3, 6 and 12 months.

• A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Rockwood Frailty Criteria.

  Rockwood Frailty Criteria: Ratio (0-1.0) based on number of positive clinical factors of a 70 item list of clinical deficits (i.e. 7/70 deficits = 0.1). Ratio score, no units of measure.

  Baseline, 3, 6 and 12 months.

Secondary Outcomes (4)

• Change in measurement of torso sarcopenia.

  Baseline, 3, 6 and 12 months.

• A change in the Modified Minnesota leisure time activities questionnaire from baseline to the one year mark.

  Baseline, 3, 6 and 12 month

• A change in mobility and activity from hospitalization to the one year mark.

  Baseline, 3, 6 and 12 months.

• Mortality

  Up to one year

Study Arms (1)

Intra-abdominal sepsis

Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.

Other: Frailty Measurements; Other: Modified Minnesota Leisure Time Activities; Other: Computed tomography morphometrics; Other: Mobility Monitors

Interventions

Frailty Measurements OTHER

A frailty index will be determined as a combination of factors. An older adult is considered physically vulnerable when they experience: 1. muscle weakness 2. fatigue 3. low physical activity, and unintentional loss in body weight, which has been agreed upon by a consensus of experts. This will be collected at baseline, 3, 6 and 12 months.

Intra-abdominal sepsis

Modified Minnesota Leisure Time Activities OTHER

A questionnaire used to assess physical activity will be administered at baseline, 3, 6 and 12 months.

Intra-abdominal sepsis

Computed tomography morphometrics OTHER

A CT scan will occur as standard of care while the patient is hospitalized. Two additional CT scans will occur at 3 and 12 months to assess for sarcopenia.

Intra-abdominal sepsis

Mobility Monitors OTHER

Mobility monitors will be placed on the patients during the duration of their hospital stay. They will then where them at 3, 6 and 12 months for up to 10 days.

Intra-abdominal sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intra-Abdominal Sepsis Patients

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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UF Health at Shands hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Efron, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 17, 2016
• Study Start: April 1, 2016
• Primary Completion: February 10, 2020
• Study Completion: February 11, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)