SepsisNCT02711709
Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty
An observational study of Sepsis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Frailty Measurements, Modified Minnesota Leisure Time Activities and Computed tomography morphometrics
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 11 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intra-Abdominal Sepsis Patients
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at Shands hospital
Gainesville, Florida, 32610
About this study
Official title: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: The Acute Development and Persistence of Frailty, Comorbidity and Disability in Critically Ill Patients After Intra-abdominal Sepsis "Induced Frailty
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.
Read the 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 clinical data collected from the parent study, pre and post-sepsis measurements of frailty, comorbidity and disability will be obtained via questionnaires and the electronic health records. Frailty, comorbidity and disability assessments will also be completed at the three, six, and 12 month follow up assessments.
Frailty measures A frailty index will be determined as a combination of factors.
An older adult is considered physically vulnerable when they experience:
- muscle weakness
- fatigue
- low physical activity, and unintentional loss in body weight, which has been agreed upon by a consensus of experts.
Two additional non-intravenous contrasted CT scans will be obtained at 3 and 12 months as part of the study protocol to assess for interval change in SMI/sarcopenia.
Objective mobility and activity monitoring will be performed to supplement assessment of frailty and disability. Wearable monitors (similar in size and appearance to a "smart watch" have received significant attention because they offer minimal burden, objectivity, versatility and low cost for assessing activity and mobility patterns. The monitor is similar in shape and size to a standard wrist watch. Thus, it will have minimal burden to patients. Each monitor will be fitted on the wrist and worn for 24 hours a day, but can be quickly removed for medical procedures, patient care or hygiene needs. Patients will wear the monitor for their entire length of stay in the hospital. It will be removed at discharge. Post-discharge, patients will be sent a monitor to wear for up to 10 days at four different time points: 3 months, 6 months and 12 months post-discharge. If study subjects are hospitalized long enough that discharge is within 30 days of the 3 month follow up, the 1 month post discharge monitoring period will be deferred. Outcomes include steps per day, total movements per day, minutes being sedentary and minutes moving at various intensities (e.g. light, moderate and vigorous).
- Conditions
- Sepsis
- Being tested
- Frailty Measurements, Modified Minnesota Leisure Time Activities, Computed tomography morphometrics, Mobility Monitors
- Keywords
- Intra-abdominal sepsis, Surgical ICU
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty MeasurementsOther
A frailty index will be determined as a combination of factors.
An older adult is considered physically vulnerable when they experience:
- muscle weakness
- fatigue
- 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.
Modified Minnesota Leisure Time ActivitiesOther
A questionnaire used to assess physical activity will be administered at baseline, 3, 6 and 12 months.
Computed tomography morphometricsOther
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.
Mobility MonitorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-abdominal sepsis | Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors. Receives: Other: Frailty Measurements; Other: Modified Minnesota Leisure Time Activities; Other: Computed tomography morphometrics; Other: Mobility Monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: 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.
Measured: Baseline, 3, 6 and 12 months.
Secondary outcomes (4)
Change in measurement of torso sarcopenia.
Sarcopenia as measured by computed tomography morphometric analysis calculation of skeletal muscle index (SMI) at the level of the 3rd lumbar vertebra at baseline as compared to 3 and 6 months after intra-abdominal sepsis. Sarcopenia is defined as SMI ≤38.5 cm2/m2 for men and ≤52.4 cm2/m2.
Measured: Baseline, 3, 6 and 12 months.
A change in the Modified Minnesota leisure time activities questionnaire from baseline to the one year mark.
This measures leisure time (both free time and domestic chores) for the 2 weeks prior to the hospitalization and at each of the above referenced time points. The raw scores are indexed to a key of activity and intensity codes, which are then utilized to calculate an Activity Metabolic Index. A healthy AMI will have an intensity code of 6.0 while a fight AMI will have intensity codes of 4.0 or less.
Measured: Baseline, 3, 6 and 12 month
A change in mobility and activity from hospitalization to the one year mark.
This is measured as total movements per day (integer, no units of measure) and steps per day (integer, no units of measure) by portable actigraphy monitors as measured during inpatient hospitalization as compared to 1-week assessments at 3, 6 and 12 months after intra-abdominal sepsis. These measurements will be aggregated and then classified by an overall intensity index (light, moderate, vigorous).
Measured: Baseline, 3, 6 and 12 months.
Mortality
Mortality will be assessed daily while the subject is in the hospital and then at post discharge follow up visits or by phone if the subject is unable to come to the follow up appointments. The Social Security mortality database will be accessed for subjects that are lost to follow up.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion10 Feb 2020
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Philip Efron, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711709
- Sponsor's protocol ID
- IRB201501027-N
- Other IDs
- P30AG028740
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: The Acute Development and Persistence of Frailty, Comorbidity and Disability in Critically Ill Patients After Intra-abdominal Sepsis "Induced Frailty
- ClinicalTrials.gov ID
- NCT02711709
- Acronym / sponsor ID
- IRB201501027-N
- Conditions
- Sepsis
- Keywords
- Intra-abdominal sepsis, Surgical ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- Apr 2016 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 clinical data collected from the parent study, pre and post-sepsis measurements of frailty, comorbidity and disability will be obtained via questionnaires and the electronic health records. Frailty, comorbidity and disability assessments will also be completed at the three, six, and 12 month follow up assessments.
Frailty measures A frailty index will be determined as a combination of factors.
An older adult is considered physically vulnerable when they experience:
- muscle weakness
- fatigue
- low physical activity, and unintentional loss in body weight, which has been agreed upon by a consensus of experts.
Two additional non-intravenous contrasted CT scans will be obtained at 3 and 12 months as part of the study protocol to assess for interval change in SMI/sarcopenia.
Objective mobility and activity monitoring will be performed to supplement assessment of frailty and disability. Wearable monitors (similar in size and appearance to a "smart watch" have received significant attention because they offer minimal burden, objectivity, versatility and low cost for assessing activity and mobility patterns. The monitor is similar in shape and size to a standard wrist watch. Thus, it will have minimal burden to patients. Each monitor will be fitted on the wrist and worn for 24 hours a day, but can be quickly removed for medical procedures, patient care or hygiene needs. Patients will wear the monitor for their entire length of stay in the hospital. It will be removed at discharge. Post-discharge, patients will be sent a monitor to wear for up to 10 days at four different time points: 3 months, 6 months and 12 months post-discharge. If study subjects are hospitalized long enough that discharge is within 30 days of the 3 month follow up, the 1 month post discharge monitoring period will be deferred. Outcomes include steps per day, total movements per day, minutes being sedentary and minutes moving at various intensities (e.g. light, moderate and vigorous).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal sepsis | – | Other: Frailty Measurements, Other: Modified Minnesota Leisure Time Activities, Other: Computed tomography morphometrics, Other: Mobility MonitorsFrailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intra-Abdominal Sepsis Patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty MeasurementsA 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 | Intra-abdominal sepsis |
| Modified Minnesota Leisure Time ActivitiesA questionnaire used to assess physical activity will be administered at baseline, 3, 6 and 12 months. | Other | Intra-abdominal sepsis |
| Computed tomography morphometricsA 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 | Intra-abdominal sepsis |
| Mobility MonitorsMobility 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. | Other | Intra-abdominal sepsis |
Primary outcome
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.
Time frame: Baseline, 3, 6 and 12 months.
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
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.
Time frame: Baseline, 3, 6 and 12 months.
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.
4 secondary outcomes
Change in measurement of torso sarcopenia.
Time frame: Baseline, 3, 6 and 12 months.
A change in the Modified Minnesota leisure time activities questionnaire from baseline to the one year mark.
Time frame: Baseline, 3, 6 and 12 month
A change in mobility and activity from hospitalization to the one year mark.
Time frame: Baseline, 3, 6 and 12 months.
Mortality
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Efron, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline, 3, 6 and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.