Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
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 |
|
Primary |
A change in the results in blood markers for persistent inflammatory state from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. |
Participant's blood will be analyzed for a persistent inflammatory state, anemia and adaptive immunosuppression. To look at whether sepsis alters the angiogenic balance between angiotensin II (ANGII), erythropoietin, and the VEGF receptor (VEGFR), and whether this imbalance is required for myeloid-derived suppressor cell (MDSC) expansion and chronic critical illness (CCI) and catabolism syndrome (PICS) development. |
Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. |
|
Primary |
A change in the results for mRNA isolation and protein biomarkers from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. |
The urine will be processed for mRNA isolation and protein biomarkers. |
Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. |
|
Primary |
A change in the results of the Dys-HDL baseline to day 4 |
Participant's blood will be analyzed to extensively characterize the temporal relationship between Dys-HDL, pertinent enzymes, and sepsis and endothelial biomarkers in patients with sepsis. |
Baseline and Day 4 |
|
Secondary |
A change in results from the Hopkins Verbal Learning Test from 3 months, 6 months and one year. |
A 12-item learning and memory test designed for brief, easy administration with proven participant tolerability in a variety of populations. The highest score is 36 and the lowest score is 12. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
3 months, 6 months and one year. |
|
Secondary |
A change in results from the Controlled Oral Word Association from 3 months, 6 months and one year. |
Measures executive function and verbal fluency. Patients are asked to generate as many words as possible beginning with specific letters. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
3 months, 6 months and one year. |
|
Secondary |
a change iin the results from the Modified Mini-Mental Status Exam from 3 months, 6 months and one year. |
A measure of global cognitive functioning. This is an expanded 100- point version of the original Folstein Modified Mini-Mental Status Exam. A score greater than or equal to 27 overall points indicates a normal cognition, below this score can indicate severe (-9), moderate (10-18) or mild (19 -24) cognitive impairment. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
3 months, 6 months and one year. |
|
Secondary |
A change in the results form the Health-related Quality of Life questionnaire from baseline, 3 months, 6 months and one year. |
The Medical Outcome Study 36-item short form (SF-36) is a measure of health-related quality of life (HRQOL). It scores eight domains of health: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality (energy/fatigue), mental health, bodily pain, social functioning, and general health perceptions on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
Baseline, 3 months, 6 months and one year. |
|
Secondary |
A change in the results from the EuroQol-5D (EQ-5D) questionnaire from baseline, 3 months, 6 months and one year. |
The EQ-5D is an HRQOL instrument with established validity in critical care survivors and as a surrogate-completed proxy measure. This tool is a descriptive system of health-related quality-of-life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
Baseline, 3 months, 6 months and one year. |
|
Secondary |
A change in the results of the Mini Nutritional Assessment Form (MNA-SF) baseline, 3 months, 6 months and one year. |
This is a validated nutrition screening and assessment tool that can identify patients who are malnourished or at risk for malnutrition. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
Baseline, 3 months, 6 months and one year. |
|
Secondary |
A change in the results of the Short Physical Performance Battery from 3 months, 6 months and one year. |
Based on a timed short-distance (4 min) walk, repeated chair stands, and balance test. A score of 0 to 4 will be determined for each component, and a summary score ranging from 0 (worst performers) to 12 (best performers) will be calculated. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
3 months, 6 months and one year. |
|
Secondary |
A change in the results of the Hand Grip Strength Measurement from baseline, day 14 or discharge from hospital, 3 months, 6 months and one year. |
Using an adjustable, hydraulic grip strength dynamometer. Three trials will be conducted for each hand. The best performance for each hand will be recorded. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
baseline, 14 days or hospital discharge, 3 months, 6 months and one year. |
|
Secondary |
A change in the results from The ECOG/WHO/Zubrod Scale from 3 months, 6 months and one year. |
A 5-point scale that measures the performance status of a patient's ambulatory nature: 0) Asymptomatic (fully active), 1) Symptomatic but completely ambulatory (restricted in physically strenuous activity), 2) Symptomatic, <50% in bed during the day (ambulatory and capable of all selfcare but unable to perform any work activities), 3) Symptomatic, >50% in bed, but not bedbound (capable of only limited self-care), 4) Bedbound (completely disabled, incapable of any self-care), and 5) Death. The test will be performed to look at the epidemiology and long-term physical and cognitive outcomes of chronic critical illness (CCI) in surgical intensive care unit (ICU) participants who survive sepsis. |
3 months, 6 months and one year. |
|
Secondary |
A change in the results from the Bioimpedance analysis from baseline, day 14 or hospital discharge, 3 months, 6 months, and one year. |
Using a Biodynamics BIA 450 to measure the content of water, muscle and fat to assess body composition |
baseline, 14 days or hospital discharge, 3 months, 6 months, and one year. |
|