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Trial record 49 of 80 for:    ASNS

PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors (PICS)

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ClinicalTrials.gov Identifier: NCT02276417
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : July 22, 2019
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
American Heart Association
Information provided by (Responsible Party):
University of Florida

Brief 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 also wants to define the long-term physical and cognitive outcomes of this disease. The investigator will be looking at many clinical variables to try to define CCI.

Condition or disease Intervention/treatment
Sepsis Other: Blood collection Other: Urine collection Other: Bioimpedance Analysis Other: Cognitive Function Tests Other: Quality-of-life Questionnaires Other: Physical Function Tests Other: Blood Collection

Detailed Description:

This is a prospective, observational study aimed at identifying the frequency, natural history and long term outcomes of CCI and PICS in the survivors of surgical or trauma-associated sepsis.

A major portion of the translational data to be obtained will be from urine and blood samples from septic patients identified in the surgery and trauma ICUs. The blood will be processed for genomic markers, inflammatory markers, immunosuppression markers, Myeloid Derived Suppressor Cells (MDSC) functions, and angiogenic factors. The urine will be processed for messenger RNA (mRNA) isolation and protein biomarkers.

Bioimpedance analysis will performed to assess body composition. In order to assess the long term outcomes, the following Quality-of-life, functional and cognitive tests will be performed.

Health-related quality of life questionnaire, EuroQol-5D, Mini Nutritional Assessment Form, the Hopkins Verbal Learning Test, Controlled Oral Word Association, Modified Mini-Mental Status Exam, Short PhysicalPerformance Battery, Hand Grip Strength Measurement and The Eastern Cooperative Oncology Group (ECOG), World Health Organization (WHO), Zubrod Scale Healthy volunteer subjects will be identified from the general population. Healthy subjects will be screened via inclusion/exclusion criteria upon contact. If appropriate for participation, the subject will be consulted for consent.


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Study Type : Observational
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: Cardiac Dysfunction in Older Sepsis Survivors
Study Start Date : January 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Sepsis
Blood Collection. Urine collection. Bioimpedance analysis. Quality-of-life questionnaires, physical function tests and cognitive function tests.
Other: Blood collection
Blood will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Blood will also be collected at the one year appointment.

Other: Urine collection
Urine will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Urine will also be collected at the one year appointment.

Other: Bioimpedance Analysis
The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.
Other Name: BIA

Other: Cognitive Function Tests
Cognitive function tests will be administered at 3, 6 and 12 months.

Other: Quality-of-life Questionnaires
Quality-of-life questionnaires will be administered at baseline, 3, 6 and 12 months.

Other: Physical Function Tests
Physical function tests will be administered at baseline, day 14 or discharge from hospital 3, 6 and 12 months.

Healthy Controls
Blood Collection.
Other: Blood Collection
The healthy volunteer participants will donate a blood sample. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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.

  2. 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. [ Time Frame: 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.

  3. A change in the results of the Dys-HDL baseline to day 4 [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. A change in results from the Hopkins Verbal Learning Test from 3 months, 6 months and one year. [ Time Frame: 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.

  2. A change in results from the Controlled Oral Word Association from 3 months, 6 months and one year. [ Time Frame: 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. a change iin the results from the Modified Mini-Mental Status Exam from 3 months, 6 months and one year. [ Time Frame: 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.

  4. A change in the results form the Health-related Quality of Life questionnaire from baseline, 3 months, 6 months and one year. [ Time Frame: 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.

  5. A change in the results from the EuroQol-5D (EQ-5D) questionnaire from baseline, 3 months, 6 months and one year. [ Time Frame: 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.

  6. A change in the results of the Mini Nutritional Assessment Form (MNA-SF) baseline, 3 months, 6 months and one year. [ Time Frame: 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.

  7. A change in the results of the Short Physical Performance Battery from 3 months, 6 months and one year. [ Time Frame: 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.

  8. 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. [ Time Frame: baseline, 14 days or hospital discharge, 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.

  9. A change in the results from The ECOG/WHO/Zubrod Scale from 3 months, 6 months and one year. [ Time Frame: 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.

  10. A change in the results from the Bioimpedance analysis from baseline, day 14 or hospital discharge, 3 months, 6 months, and one year. [ Time Frame: baseline, 14 days 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


Other Outcome Measures:
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are looking at all patients admitted to the surgical and trauma ICUs that have been entered into the sepsis protocol.
Criteria

Inclusion Criteria:

  • presence in the surgery or trauma intensive care unit (ICU) at University of Florida (UF) Health Shands Hospital where clinical care can be managed by surgical critical care guided by standard operating procedures.
  • age of ≥18 years
  • placed on EMR sepsis protocol with sepsis/septic shock by Sepsis-3 criteriad
  • ability to obtain informed consent.

Exclusion Criteria:

  • patients deemed to be futile care or have advanced care directives or goals of care limiting resuscitative efforts.
  • severe traumatic brain injury (evidence of neurologic injury on CT scan and a Glasgow Coma Scale (GCS) <8 after resuscitation).
  • refractory shock (i.e., patients who die within 12 hours).
  • uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
  • severe Congestive Heart Failure (CHF) (NY Heart Association Class IV)
  • severe chronic liver disease (Childs-Pugh Class B/C and /or MELD > 14) or pre-liver transplant.
  • known HIV infection with CD4 count <200 cells/mm3
  • organ transplant recipient on immunosuppressive agents
  • known pregnancy
  • prisoners
  • institutionalized patients
  • inability to obtain informed consent.
  • pre-hospital bedridden status (WHO/Zubrod score ≥ 4).
  • patient's with an exacerbation of historic CVD or new onset CVD
  • alternative or confounding diagnosis causing shock state (e.g. MI or PE)
  • enrollment > 96 hours after suspected sepsis onset.
  • pre-existing state of Chronic critical illness (ICU LOS ≥ 14 days, includes outside facility)
  • interfacility transfer patients with > 96 hour critical illness prior to transfer.
  • subsequent clinical adjudication not consistent with sepsis/septic shock by Sepsis-3 criteria

Healthy Controls

Inclusion criteria will be:

  • all adults (age ≥18)
  • Ability to obtain Informed Consent prior to blood collection.

Exclusion Criteria will be:

  • Current, chronic steroid use
  • Pregnancy

Information from the National Library of Medicine

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): NCT02276417


Contacts
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Contact: Jennifer Lanz, MSN 352-273-5497 jennifer.lanz@surgery.ufl.edu
Contact: Ruth Davis, ASN ruth.davis@surgery.ufl.edu

Locations
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United States, Florida
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Jennifer Lanz, MSN    352-273-5497    jennifer.lanz@surgery.ufl.edu   
Contact: Ruth Davis, ASN    352-273-5497    ruth.davis@surgery.ufl.edu   
Principal Investigator: Scott Brakenridge, MD         
Sub-Investigator: Lyle Moldawer, PhD         
Sponsors and Collaborators
University of Florida
National Institute of General Medical Sciences (NIGMS)
American Heart Association
Investigators
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Principal Investigator: Scott Brakenridge, MD University of Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02276417     History of Changes
Other Study ID Numbers: IRB201400611-N
P50GM111152-01 ( U.S. NIH Grant/Contract )
OCR14760 ( Other Identifier: Universiy of Florida )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Sepsis
Surgical ICU
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes