Monitoring Tools for Sepsis-Related Frailty

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Traumatic brain injury, Refractory shock, Advanced cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

53 Participants Needed

Trial Summary

What is the purpose of this trial?

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 wants to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of this research study is to define the acute changes in frailty (weakness, slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and performing routine daily functions) after having an infection that is located in the abdominal cavity or torso. The investigator believes having severe infection contributes to acute and permanent changes in these areas, especially in those of advanced age.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chemotherapy, radiotherapy, or immunosuppressive agents, you may not be eligible to participate.

What data supports the effectiveness of the treatment Monitoring Tools for Sepsis-Related Frailty?

Research shows that frailty assessments can help predict mortality and disability in elderly patients with sepsis, suggesting that monitoring frailty could be useful in managing sepsis-related health issues. ^{1 2 3 4 5}

How does this treatment for sepsis-related frailty differ from other treatments?

This treatment is unique because it focuses on monitoring tools specifically designed to assess frailty in patients with sepsis, which is a novel approach compared to traditional treatments that may not consider frailty as a key factor. By targeting frailty, this treatment aims to improve outcomes by addressing the vulnerability and physical decline often seen in these patients. ^{1 2 3 5 6}

Research Team

Philip Efron, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults over 18 who are in the surgical or trauma ICU with a diagnosis of sepsis, severe sepsis, or septic shock. They must be part of the standard-care sepsis protocol and able to give consent themselves or through a legal representative.

Inclusion Criteria

You are currently enrolled in the standard treatment for sepsis.

You have been diagnosed with a severe infection called sepsis.

You, or someone legally allowed to make decisions for you, can give permission for you to take part in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-Hospital Monitoring

Participants are monitored for frailty, comorbidity, and disability during their hospital stay after intra-abdominal sepsis

Length of hospital stay

Continuous monitoring

Post-Discharge Monitoring

Participants are monitored for changes in frailty, mobility, and sarcopenia at 3, 6, and 12 months post-discharge

12 months

4 monitoring periods (3, 6, 12 months post-discharge)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Computed tomography morphometrics
• Frailty Measurements
• Mobility Monitors
• Modified Minnesota Leisure Time Activities

Trial Overview The study aims to understand how serious abdominal infections affect frailty, existing health conditions, and daily function. It involves measuring frailty levels, leisure activities impact on health, body muscle mass via CT scans, and mobility tracking.

Participant Groups

Group I: Intra-abdominal sepsis Experimental Treatment 4 Interventions

Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Relationship between community walking ability and in-hospital mortality in elderly patients with sepsis: a single-center retrospective cohort study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Patient characteristics in sepsis-related deaths: prevalence of advanced frailty, comorbidity, and age in a Norwegian hospital trust. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Predictive Value of Frailty Index in Comparison to Traditional Markers of Sepsis in Predicting Mortality among Elderly Admitted in Tertiary Care Hospital. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The feasibility of measuring frailty to predict disability and mortality in older medical intensive care unit survivors. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Frailty Syndrome and Risk of Sepsis in the REasons for Geographic And Racial Differences in Stroke (REGARDS) Cohort. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Frailty in the critically ill: a novel concept. [2022]