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

NCT02711709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2026-04-16

No results posted yet for this study

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

Interventions

OTHER

Frailty Measurements

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.

OTHER

Modified Minnesota Leisure Time Activities

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

OTHER

Computed tomography morphometrics

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.

OTHER

Mobility Monitors

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Philip Efron, MD · University of Florida

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-02-10
Completion
2026-02-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711709 on ClinicalTrials.gov