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

NCT ID NCT02276417

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

668 people

The number who actually took part.

Started

Jan 2015

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

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