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Hidden toll of sepsis: study reveals lasting frailty after ICU

NCT ID NCT02711709

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 53 ICU patients who had severe abdominal infections to understand why many become frail, weak, and disabled long after leaving the hospital. Researchers measured changes in frailty, muscle loss, and overall health over 12 months. The goal was to define the natural course of chronic critical illness, not to test a treatment.

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

53 people

The number who actually took part.

Started

Apr 2016

Finished

Feb 2026

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

Intra-Abdominal Sepsis Patients

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Admission to the surgery or trauma ICU where clinical care can be managed by surgical critical care guided by standard operating procedures. * Age ≥18 years * Diagnosis of sepsis, severe sepsis, or septic shock * Entrance into the standard-of-care sepsis protocol * Ability to obtain patient/legally authorized representative informed consent. Exclusion Criteria: * Significant traumatic brain injury (evidence of neurologic injury on CT scan and a best Glascow Coma Scale \<8 within 24 hours of injury) * Refractory shock (i.e., patients who die within 12 hours) * Alternative or confounding diagnosis causing shock state (e.g., myocardial infarction or pulmonary embolus) * Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel), * Patients deemed to be futile care or have advanced care directives limiting resuscitative efforts such as patient or patient's family who are not committed to aggressive management of the patient's condition. Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. Recurrent, advanced or metastatic cancer). * Severe Congestive Heart Failure (NY Heart Association Class IV) * Child-Pugh Class C liver disease or pre-liver transplant. * Known HIV infection with CD4 count\<200 cells/mm3, * Organ transplant recipient on immunosuppressive agents * Known pregnancy * Inability to obtain informed consent * Prisoners * Institutionalized patients * Chemotherapy or radiotherapy within 30 days prior to sepsis * Spinal cord injuries resulting in permanent sensory and/or motor deficits.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Sepsis

Contacts and locations

Locations

  • UF Health at Shands hospital

    Gainesville, Florida, 32610, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.