PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

668 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2026-07-24

Brief Summary

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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 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.

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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis

Blood Collection. Urine collection. Bioimpedance analysis. Quality-of-life questionnaires, physical function tests and cognitive function tests.

Blood collection

Intervention Type OTHER

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.

Urine collection

Intervention Type OTHER

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.

Bioimpedance Analysis

Intervention Type OTHER

The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.

Cognitive Function Tests

Intervention Type OTHER

Cognitive function tests will be administered at 3, 6 and 12 months.

Quality-of-life Questionnaires

Intervention Type OTHER

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

Physical Function Tests

Intervention Type OTHER

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

Healthy Controls

Blood Collection.

Blood Collection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Bioimpedance Analysis

The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.

Intervention Type OTHER

Cognitive Function Tests

Cognitive function tests will be administered at 3, 6 and 12 months.

Intervention Type OTHER

Quality-of-life Questionnaires

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

Intervention Type OTHER

Physical Function Tests

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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BIA

Eligibility Criteria

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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.

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

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

* Current, chronic steroid use
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes