Urine collection / Bioimpedance Analysis / Cognitive Function Tests · Observational Study

PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective observational study registered to characterize inflammatory biomarkers, mRNA, protein markers, and HDL dysfunction in older adults during and after sepsis-related critical illness, with follow-up to one year. No results are reported in this registry record; the study is active but recruitment is closed.

What was studied

Observational. Sepsis; age from 18 Years; accepts healthy volunteers. Intervention: Sepsis; Healthy Controls. n = 668. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active observational registry record with no reported results; it describes an ongoing study designed to characterize biomarkers and outcomes in sepsis survivors.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: A change in the results in blood markers for persistent inflammatory state from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. (assessed at Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one…); A change in the results for mRNA isolation and protein biomarkers from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. (assessed at Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one…); A change in the re…

DesignObservational

PopulationSepsis; age from 18 Years; accepts healthy volunteers

Sample size668

InterventionSepsis; Healthy Controls

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size668

Study typeObservational

Primary outcome measure 1Change in blood markers for persistent inflammatory state from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year

Primary outcome measure 2Change in mRNA isolation and protein biomarkers from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year

Primary outcome measure 3Change in Dys-HDL from baseline to day 4

Follow-up durationOne year

Caveats

This is a registry record only; no results are reported.
Study outcome data, effect sizes, and clinical findings are not available in this source.
Population age criteria and detailed inclusion/exclusion criteria are not fully specified in the registry excerpt.
No comparator group or control arm is described; observational design limits causal inference.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design; no control group or randomization stated.

Directness

moderate

Measures biomarkers and functional outcomes in sepsis survivors; clinical relevance present.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not detail blinding, allocation concealment, or follow-up procedures.

Sample adequacy

moderate

668 participants enrolled; sample size adequate for descriptive and exploratory analysis.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02276417). This is a study registration, not published results. Lead sponsor: University of Florida. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 668 participants (ACTUAL). Conditions: Sepsis. Interventions: OTHER: Blood collection; OTHER: Urine collection; OTHER: Bioimpedance Analysis; OTHER: Cognitive Function Tests; OTHER: Quality-of-life Questionnaires; OTHER: Physical Function Tests; OTHER: Blood Collection. Primary outcome measures: A change in the results in blood markers for persistent inflammatory state from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. , Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year.; A change in the results for mRNA isolation and protein biomarkers from baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year. , Baseline, Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, and one year.; A change in the results of the Dys-HDL baseline to day 4 , Baseline and Day 4. Brief summary: 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 also wants to define the long-term physical and cognitive outcomes of this disease. The investigator will be looking at many clinical variables to try to define CCI.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Urine collectionUniversity of FloridaBioimpedance AnalysisNCT02276417Cognitive Function TestsSepsisBlood collection