Why do some sepsis survivors never fully recover? researchers map the long road back
NCT ID NCT02276417
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
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668 people
The number who actually took part.
- Started
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Jan 2015
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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UF Health Shands Hospital
Gainesville, Florida, 32610, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?
- Stem cells put to the test against Sepsis's immune chaos
- Can the immune system reveal who will suffer kidney injury after sepsis?
- A routine calcium reading could reveal how sick a sepsis patient really is