Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty
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|ClinicalTrials.gov Identifier: NCT02711709|
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Other: Frailty Measurements Other: Modified Minnesota Leisure Time Activities Other: Computed tomography morphometrics Other: Mobility Monitors||Not Applicable|
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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||December 2020|
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
Other: Frailty Measurements
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.
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.
- 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.
- Change in measurement of torso sarcopenia. [ Time Frame: Baseline, 3, 6 and 12 months. ]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.
- 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 ]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.
- A change in mobility and activity from hospitalization to the one year mark. [ Time Frame: Baseline, 3, 6 and 12 months. ]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).
- Mortality [ Time Frame: Up to one year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711709
|Contact: Jennifer Lanz, MSNfirstname.lastname@example.org|
|Contact: Ruth Davis, BSNemail@example.com|
|United States, Florida|
|UF Health at Shands hospital||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Jennifer Lanz, MSN 352-273-5497 firstname.lastname@example.org|
|Contact: Ruth Davis, ASN 325-273-5497 email@example.com|
|Principal Investigator:||Scott Brakenridge, MD||University of Florida|