Monitoring Tools for Sepsis-Related Frailty

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how severe abdominal infections, known as sepsis, impact frailty, which includes weakness, slowness, and loss of muscle mass. Researchers seek to understand how these infections affect mobility and the ability to perform daily tasks. They use tools like imaging tests (such as computed tomography morphometrics), activity monitors, and mobility assessments to gather data. The trial is best suited for surgical ICU patients who have experienced sepsis, particularly those with abdominal infections. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance understanding and treatment of sepsis-related frailty.

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 prior data suggests that these monitoring tools are safe for sepsis-related frailty?

Research has shown that the tools and methods used in this study are generally safe for people. For CT scans, studies have found them crucial for doctors to locate infection sites in patients with sepsis. Although CT scans are commonly used and well-tolerated, they do involve some radiation exposure.

Frailty measurements are also part of this study. These assessments help predict health risks in older adults with sepsis. Being non-invasive, they don't involve surgery or entering the body, making them safe.

Mobility monitors, such as wearable devices, track movement and activity. Studies show they can help detect health changes early. These devices are usually safe and easy to wear.

Lastly, the Modified Minnesota Leisure Time Activities questionnaire measures physical activity. This simple survey method poses no risk to participants.

Overall, the tools in this study are widely accepted and safe. They help doctors understand how severe infections affect health, especially in older people.12345

Why are researchers excited about this trial?

Researchers are excited about these new monitoring tools for sepsis-related frailty because they offer a comprehensive approach that goes beyond traditional treatments. Unlike standard methods that primarily focus on managing infection, these tools incorporate frailty measurements, mobility monitors, and specialized activity tracking to better understand a patient's overall health status. By using computed tomography morphometrics, they can precisely measure body composition changes, providing insights into how sepsis impacts physical resilience. This holistic approach could lead to more personalized treatments, potentially improving recovery outcomes for patients with sepsis.

What evidence suggests that this trial's monitoring tools could be effective for sepsis-related frailty?

This trial will use various monitoring tools to understand sepsis-related frailty. Research has shown that frailty and muscle loss can worsen outcomes for people with sepsis. In this trial, CT scans will identify muscle loss, which links to slower recovery. Frailty measurements will predict negative outcomes, as frail patients often face more challenges in recovery. Mobility monitors will track movement to uncover difficulties in physical activity after sepsis, which is crucial for understanding recovery. Finally, the Modified Minnesota Leisure Time Activities questionnaire will assess physical activity levels, indicating overall health and recovery potential. Together, these tools aim to improve outcomes for sepsis patients.24678

Who Is on the Research Team?

PE

Philip Efron, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Intra-abdominal sepsisExperimental Treatment4 Interventions

Find a Clinic Near You

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+

Citations

Impact of sarcopenia and frailty on outcomes of patients with ...Sarcopenia and frailty are emerging risk factors that may modify outcomes in patients with sepsis or septic shock.
Computed tomography-based body composition is ...Computed tomography-based body composition may help risk stratification and predict the prognosis for older patients with sepsis.
Prevalence of sarcopenia and its association with frailty and ...This study aimed to investigate the prevalence of sarcopenia among older patients with sepsis and explore its association with specific geriatric symptoms: ...
Impact of sarcopenia and frailty on outcomes of patients ...Conclusion: A loss of muscle mass, as evaluated by CT scan, was associated with a poor outcome in sepsis. View full-text. Last Updated: 27 ...
Critical reflection on the indication for computed tomography ...In patients with sepsis, contrast-enhanced CT (CECT) can be conducted to detect septic foci, to better assess the exact extent of the infection, ...
Body computed tomography in sepsis: predictors of CT ...A full-text search in the radiological information system (RIS) retrieved 227 body CT examinations conducted to identify infectious sources in 2018.
Biomarkers and Clinical Evaluation in the Detection of FrailtyFrailty is a complex biological process that is associated with adverse outcomes in community-dwelling and hospitalized patients. While clinical evaluation ...
derived skeletal muscle mass and short- and long-term ...CT-assessed skeletal muscle mass at the lumbar level on admission to ICU is associated with both short- and long-term mortality.
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