NCT05912413

Brief Summary

This study addresses critically ill sepsis patients' current literature reports of ongoing post-hospital discharge weakness and hospital readmissions. This study is aimed at capture and interpretation of a complex set of tests, administered during a subject's sepsis functional recovery trajectory, particularly capturing hospital readmission's effects on survivors' physical function recovery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jul 2023Dec 2027

First Submitted

Initial submission to the registry

June 2, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

June 2, 2023

Last Update Submit

February 17, 2026

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Short Performance Physical Battery

    Physical function score

    3 months post hospital discharge

Interventions

there is no interventionOTHER

there is no intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sepsis requiring organ support in an ICU setting

You may qualify if:

  • Sepsis requiring organ support in an ICU setting

You may not qualify if:

  • inability to obtain informed consent
  • the attending physician reports that the patient's goals of care are transitioning to palliation/withdrawal of life-sustaining therapy
  • recent cancer therapy in the last 12 months
  • age \>80
  • plans to be discharged on mechanical ventilation to a Long Term Acute Care Hospital
  • planned discharge to rehabilitation facility, long-term hospital or nursing home.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • peter morris, md

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

peter morris, md

CONTACT

(205) 934-5555pmorris@uabmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 22, 2023

Study Start

July 11, 2023

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)