PICS: Subtitle Cardiac Dysfunction in Older Sepsis Survivors

NCT02276417 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 668

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Blood collection

Blood will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Blood will also be collected at the one year appointment.

OTHER

Urine collection

Urine will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Urine will also be collected at the one year appointment.

OTHER

Bioimpedance Analysis

The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.

OTHER

Cognitive Function Tests

Cognitive function tests will be administered at 3, 6 and 12 months.

OTHER

Quality-of-life Questionnaires

Quality-of-life questionnaires will be administered at baseline, 3, 6 and 12 months.

OTHER

Physical Function Tests

Physical function tests will be administered at baseline, day 14 or discharge from hospital 3, 6 and 12 months.

OTHER

Blood Collection

The healthy volunteer participants will donate a blood sample. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • American Heart Association

    collaborator OTHER
  • University of Florida

    lead OTHER

Principal Investigators

  • Philip Efron, MD · University of Florida

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2022-07-22
Completion
2026-07-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276417 on ClinicalTrials.gov