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Why do some sepsis survivors never fully recover? researchers map the long road back

NCT ID NCT02276417

What the study statuses mean

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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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers at the University of Florida are studying sepsis survivors in the surgical intensive care unit to understand why some develop chronic critical illness, a condition marked by persistent inflammation, immune suppression, and muscle wasting. The trial follows 668 adults, collecting blood and urine samples over time and testing heart function, physical strength, and memory. The goal is to define the natural history of this syndrome and identify markers that predict long-term physical and cognitive problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers map how sepsis turns into chronic critical illness, doctors could spot the warning signs earlier and design treatments that prevent long-term damage to the heart and brain.
What could go wrong
This is an observational study, so it cannot prove what causes chronic critical illness or whether any treatment works. The findings may not apply to sepsis patients outside surgical intensive care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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