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Monitoring Tools for Sepsis-Related Frailty
N/A
Waitlist Available
Led By Scott Brakenridge, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
No Placebo-Only Group
Summary
This trial will help researchers understand more about what happens to patients after they experience sepsis, specifically those who develop chronic critical illness.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on observations rather than treatments or medications, there are no direct side effects from interventions being tested. However, monitoring may involve some discomfort due to wearing devices or undergoing scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Fried Frailty Criteria.
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Rockwood Frailty Criteria.
Secondary study objectives
A change in mobility and activity from hospitalization to the one year mark.
A change in the Modified Minnesota leisure time activities questionnaire from baseline to the one year mark.
Change in measurement of torso sarcopenia.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intra-abdominal sepsisExperimental Treatment4 Interventions
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,846 Total Patients Enrolled
2 Trials studying Sepsis
352 Patients Enrolled for Sepsis
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,170 Total Patients Enrolled
20 Trials studying Sepsis
7,669 Patients Enrolled for Sepsis
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,567 Total Patients Enrolled
13 Trials studying Sepsis
9,678 Patients Enrolled for Sepsis
Scott Brakenridge, MDPrincipal InvestigatorUniversity of Florida
Philip Efron, MDPrincipal InvestigatorUniversity of Florida
7 Previous Clinical Trials
2,321 Total Patients Enrolled
4 Trials studying Sepsis
1,841 Patients Enrolled for Sepsis