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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG028740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-abdominal sepsis | Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frailty Measurements | Other | A frailty index will be determined as a combination of factors. An older adult is considered physically vulnerable when they experience:
This will be collected at baseline, 3, 6 and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3, 6 and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Intra-Abdominal Sepsis Patients
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| Name | Affiliation | Role |
|---|---|---|
| Philip Efron, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at Shands hospital | Gainesville | Florida | 32610 | United States |
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| Modified Minnesota Leisure Time Activities | Other | A questionnaire used to assess physical activity will be administered at baseline, 3, 6 and 12 months. |
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| 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. |
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| 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. |
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| 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. | 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). | 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. | Up to one year |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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