SepsisPICSNCT02276417

PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors

An observational study of Sepsis, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sepsis
What is being tested?: Blood collection, Urine collection and Bioimpedance Analysis
How many people: 668 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 24 Jul 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: We are looking at all patients admitted to the surgical and trauma ICUs that have been entered into the sepsis protocol.

Who may be able to join

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.

Who cannot join

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.

Show all 22Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UF Health Shands Hospital
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: Cardiac Dysfunction in Older Sepsis Survivors Subtitle: Development of a Designer Proline-Rich Antimicrobial Peptide Chaperone Protein Inhibitor (DPC) for Treating Sepsis

Read the 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.

Conditions: Sepsis
Being tested: Blood collection, Urine collection, Bioimpedance Analysis, Cognitive Function Tests, Quality-of-life Questionnaires
Keywords: Sepsis, Surgical ICU
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood collectionOther
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 collectionOther
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 AnalysisOther
Also called BIA
The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.
Cognitive Function TestsOther
Cognitive function tests will be administered at 3, 6 and 12 months.
Quality-of-life QuestionnairesOther
Quality-of-life questionnaires will be administered at baseline, 3, 6 and 12 months.
Physical Function TestsOther
Physical function tests will be administered at baseline, day 14 or discharge from hospital 3, 6 and 12 months.
Blood CollectionOther
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.

Study groups in NCT02276417
Study group	Role	What they receive
Sepsis		Blood Collection. Urine collection. Bioimpedance analysis. Quality-of-life questionnaires, physical function tests and cognitive function tests. Receives: Other: Blood collection; Other: Urine collection; Other: Bioimpedance Analysis; Other: Cognitive Function Tests; Other: Quality-of-life Questionnaires; Other: Physical Function Tests
Healthy Controls		Blood Collection. Receives: Other: Blood Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year.
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.
Measured: Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year.
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.
Measured: Baseline and Day 4

Secondary outcomes (10)

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.
Measured: 3 months, 6 months and one year.
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.
Measured: 3 months, 6 months and one year.
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.
Measured: 3 months, 6 months and one year.
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.
Measured: Baseline, 3 months, 6 months and one year.
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.
Measured: Baseline, 3 months, 6 months and one year.
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.
Measured: Baseline, 3 months, 6 months and one year.
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.
Measured: 3 months, 6 months and one year.
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.
Measured: baseline, 14 days or hospital discharge, 3 months, 6 months and one year.
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.
Measured: 3 months, 6 months and one year.
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
Measured: baseline, 14 days or hospital discharge, 3 months, 6 months, and one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201524 Jul 2027

First posted28 Oct 2014 (estimated)
Study startJan 2015
Primary completion22 Jul 2022
Study completion24 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 668 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02276417
Sponsor's protocol ID: IRB201400611-N
Other IDs: P50GM111152-01, OCR14760
Acronym: PICS
Status last verified: Sep 2026
First submitted: 15 Oct 2014
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Barrios EL, Balzano-Nogueira L, Polcz VE, Rodhouse C, Leary JR, Darden DB, Rincon JC, Dirain ML, Ungaro R, Nacionales DC, Larson SD, Sharma A, Upchurch G, Wallet SM, Brusko TM, Loftus TJ, Mohr AM, Maile R, Bacher R, Cai G, Kladde MP, Mathews CE, Moldawer LL, Brusko MA, Efron PA. Unique lymphocyte transcriptomic profiles in septic patients with chronic critical illness. Front Immunol. 2024 Dec 3;15:1478471. doi: 10.3389/fimmu.2024.1478471. eCollection 2024.
PubMed 39691721
Barrios EL, Leary JR, Darden DB, Rincon JC, Willis M, Polcz VE, Gillies GS, Munley JA, Dirain ML, Ungaro R, Nacionales DC, Gauthier ML, Larson SD, Morel L, Loftus TJ, Mohr AM, Maile R, Kladde MP, Mathews CE, Brusko MA, Brusko TM, Moldawer LL, Bacher R, Efron PA. The post-septic peripheral myeloid compartment reveals unexpected diversity in myeloid-derived suppressor cells. Front Immunol. 2024 Apr 24;15:1355405. doi: 10.3389/fimmu.2024.1355405. eCollection 2024.
PubMed 38720891
Barrios EL, Rincon JC, Willis M, Polcz VE, Leary JR, Darden DB, Balch JA, Larson SD, Loftus TJ, Mohr AM, Wallet S, Brusko MA, Balzano-Nogueira L, Cai G, Sharma A, Upchurch GR Jr, Kladde MP, Mathews CE, Maile R, Moldawer LL, Bacher R, Efron PA. TRANSCRIPTOMIC DIFFERENCES IN PERIPHERAL MONOCYTE POPULATIONS IN SEPTIC PATIENTS BASED ON OUTCOME. Shock. 2024 Aug 1;62(2):208-216. doi: 10.1097/SHK.0000000000002379. Epub 2024 May 2.
PubMed 38713581
Stortz JA, Cox MC, Hawkins RB, Ghita GL, Brumback BA, Mohr AM, Moldawer LL, Efron PA, Brakenridge SC, Moore FA. Phenotypic heterogeneity by site of infection in surgical sepsis: a prospective longitudinal study. Crit Care. 2020 May 7;24(1):203. doi: 10.1186/s13054-020-02917-3.
PubMed 32381107
Hollen MK, Stortz JA, Darden D, Dirain ML, Nacionales DC, Hawkins RB, Cox MC, Lopez MC, Rincon JC, Ungaro R, Wang Z, Wu Q, Brumback B, Gauthier ML, Kladde M, Leeuwenburgh C, Segal M, Bihorac A, Brakenridge S, Moore FA, Baker HV, Mohr AM, Moldawer LL, Efron PA. Myeloid-derived suppressor cell function and epigenetic expression evolves over time after surgical sepsis. Crit Care. 2019 Nov 13;23(1):355. doi: 10.1186/s13054-019-2628-x.
PubMed 31722736
Brakenridge SC, Moore FA, Mercier NR, Cox M, Wu Q, Moldawer LL, Mohr AM, Efron PA, Smith RS. Persistently Elevated Glucagon-Like Peptide-1 Levels among Critically Ill Surgical Patients after Sepsis and Development of Chronic Critical Illness and Dismal Long-Term Outcomes. J Am Coll Surg. 2019 Jul;229(1):58-67.e1. doi: 10.1016/j.jamcollsurg.2019.04.014. Epub 2019 Apr 13.
PubMed 30991107
Gardner AK, Ghita GL, Wang Z, Ozrazgat-Baslanti T, Raymond SL, Mankowski RT, Brumback BA, Efron PA, Bihorac A, Moore FA, Anton SD, Brakenridge SC. The Development of Chronic Critical Illness Determines Physical Function, Quality of Life, and Long-Term Survival Among Early Survivors of Sepsis in Surgical ICUs. Crit Care Med. 2019 Apr;47(4):566-573. doi: 10.1097/CCM.0000000000003655.
PubMed 30664526
Stortz JA, Mira JC, Raymond SL, Loftus TJ, Ozrazgat-Baslanti T, Wang Z, Ghita GL, Leeuwenburgh C, Segal MS, Bihorac A, Brumback BA, Mohr AM, Efron PA, Moldawer LL, Moore FA, Brakenridge SC. Benchmarking clinical outcomes and the immunocatabolic phenotype of chronic critical illness after sepsis in surgical intensive care unit patients. J Trauma Acute Care Surg. 2018 Feb;84(2):342-349. doi: 10.1097/TA.0000000000001758.
PubMed 29251709

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: Cardiac Dysfunction in Older Sepsis Survivors Subtitle: Development of a Designer Proline-Rich Antimicrobial Peptide Chaperone Protein Inhibitor (DPC) for Treating Sepsis
ClinicalTrials.gov ID: NCT02276417
Acronym / sponsor ID: PICS / IRB201400611-N
Conditions: Sepsis
Keywords: Sepsis, Surgical ICU
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 668 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS), American Heart Association
Study start: Jan 2015 (actual)
Primary completion: 22 Jul 2022 (actual)
Study completion: 24 Jul 2027 (estimated)
First posted: 28 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Sepsis	–	Other: Blood collection, Other: Urine collection, Other: Bioimpedance Analysis, Other: Cognitive Function Tests, Other: Quality-of-life Questionnaires, Other: Physical Function TestsBlood Collection. Urine collection. Bioimpedance analysis. Quality-of-life questionnaires, physical function tests and cognitive function tests.
Healthy Controls	–	Other: Blood CollectionBlood Collection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: We are looking at all patients admitted to the surgical and trauma ICUs that have been entered into the sepsis protocol.

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (22 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood collectionBlood 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	Sepsis
Urine collectionUrine 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	Sepsis
Bioimpedance AnalysisAlso: BIAThe bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.	Other	Sepsis
Cognitive Function TestsCognitive function tests will be administered at 3, 6 and 12 months.	Other	Sepsis
Quality-of-life QuestionnairesQuality-of-life questionnaires will be administered at baseline, 3, 6 and 12 months.	Other	Sepsis
Physical Function TestsPhysical function tests will be administered at baseline, day 14 or discharge from hospital 3, 6 and 12 months.	Other	Sepsis
Blood CollectionThe 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.	Other	Healthy Controls

Primary outcome

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.
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.
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.

10 secondary outcomes

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 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.
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 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.
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.
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.
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.
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.
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 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Derived from this study: PubMed 39691721Barrios EL, Balzano-Nogueira L, Polcz VE, Rodhouse C, Leary JR, Darden DB, Rincon JC, Dirain ML, Ungaro R, Nacionales DC, Larson SD, Sharma A, Upchurch G, Wallet SM, Brusko TM, Loftus TJ, Mohr AM, Maile R, Bacher R, Cai G, Kladde MP, Mathews CE, Moldawer LL, Brusko MA, Efron PA. Unique lymphocyte transcriptomic profiles in septic patients with chronic critical illness. Front Immunol. 2024 Dec 3;15:1478471. doi: 10.3389/fimmu.2024.1478471. eCollection 2024.
Derived from this study: PubMed 38720891Barrios EL, Leary JR, Darden DB, Rincon JC, Willis M, Polcz VE, Gillies GS, Munley JA, Dirain ML, Ungaro R, Nacionales DC, Gauthier ML, Larson SD, Morel L, Loftus TJ, Mohr AM, Maile R, Kladde MP, Mathews CE, Brusko MA, Brusko TM, Moldawer LL, Bacher R, Efron PA. The post-septic peripheral myeloid compartment reveals unexpected diversity in myeloid-derived suppressor cells. Front Immunol. 2024 Apr 24;15:1355405. doi: 10.3389/fimmu.2024.1355405. eCollection 2024.
Derived from this study: PubMed 38713581Barrios EL, Rincon JC, Willis M, Polcz VE, Leary JR, Darden DB, Balch JA, Larson SD, Loftus TJ, Mohr AM, Wallet S, Brusko MA, Balzano-Nogueira L, Cai G, Sharma A, Upchurch GR Jr, Kladde MP, Mathews CE, Maile R, Moldawer LL, Bacher R, Efron PA. TRANSCRIPTOMIC DIFFERENCES IN PERIPHERAL MONOCYTE POPULATIONS IN SEPTIC PATIENTS BASED ON OUTCOME. Shock. 2024 Aug 1;62(2):208-216. doi: 10.1097/SHK.0000000000002379. Epub 2024 May 2.
Derived from this study: PubMed 32381107Stortz JA, Cox MC, Hawkins RB, Ghita GL, Brumback BA, Mohr AM, Moldawer LL, Efron PA, Brakenridge SC, Moore FA. Phenotypic heterogeneity by site of infection in surgical sepsis: a prospective longitudinal study. Crit Care. 2020 May 7;24(1):203. doi: 10.1186/s13054-020-02917-3.
Derived from this study: PubMed 31722736Hollen MK, Stortz JA, Darden D, Dirain ML, Nacionales DC, Hawkins RB, Cox MC, Lopez MC, Rincon JC, Ungaro R, Wang Z, Wu Q, Brumback B, Gauthier ML, Kladde M, Leeuwenburgh C, Segal M, Bihorac A, Brakenridge S, Moore FA, Baker HV, Mohr AM, Moldawer LL, Efron PA. Myeloid-derived suppressor cell function and epigenetic expression evolves over time after surgical sepsis. Crit Care. 2019 Nov 13;23(1):355. doi: 10.1186/s13054-019-2628-x.
Derived from this study: PubMed 30991107Brakenridge SC, Moore FA, Mercier NR, Cox M, Wu Q, Moldawer LL, Mohr AM, Efron PA, Smith RS. Persistently Elevated Glucagon-Like Peptide-1 Levels among Critically Ill Surgical Patients after Sepsis and Development of Chronic Critical Illness and Dismal Long-Term Outcomes. J Am Coll Surg. 2019 Jul;229(1):58-67.e1. doi: 10.1016/j.jamcollsurg.2019.04.014. Epub 2019 Apr 13.
Derived from this study: PubMed 30664526Gardner AK, Ghita GL, Wang Z, Ozrazgat-Baslanti T, Raymond SL, Mankowski RT, Brumback BA, Efron PA, Bihorac A, Moore FA, Anton SD, Brakenridge SC. The Development of Chronic Critical Illness Determines Physical Function, Quality of Life, and Long-Term Survival Among Early Survivors of Sepsis in Surgical ICUs. Crit Care Med. 2019 Apr;47(4):566-573. doi: 10.1097/CCM.0000000000003655.
Derived from this study: PubMed 29251709Stortz JA, Mira JC, Raymond SL, Loftus TJ, Ozrazgat-Baslanti T, Wang Z, Ghita GL, Leeuwenburgh C, Segal MS, Bihorac A, Brumback BA, Mohr AM, Efron PA, Moldawer LL, Moore FA, Brakenridge SC. Benchmarking clinical outcomes and the immunocatabolic phenotype of chronic critical illness after sepsis in surgical intensive care unit patients. J Trauma Acute Care Surg. 2018 Feb;84(2):342-349. doi: 10.1097/TA.0000000000001758.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Efron, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276417, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.