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NCT Number: NCT05912413

Predicton of Sepsis Recovery Performance Subtypes Pilot Study

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Peter Morris, MD

CONTACT

[email protected]

(205) 975-6376

About this study

Patients with Sepsis who require ICU care, experience frequent weakness, physical dysfunction, fatigue, difficulty concentrating, poor memory, and mental morbidity that persists after hospital discharge. This syndromic pattern has been labeled as Post Intensive Care Syndrome (PICS) or Post Sepsis Syndrome (PSS). These patients are at increased risk of rehospitalization (up to 40% at 6 months). Studies have pointed out that sepsis survivors recover within several different recovery patterns or trajectories. Unfortunately there are no objective biomarkers early in these patients' hospitalizations, to predict which physical function trajectory a sepsis survivor will experience. However, a very common, unifying symptom of sepsis survivors is weakness. The literature maintains that an intervention of exercise rehabilitation remains a safe and potential therapy for sepsis survivors. It is important to note that as of yet, there has been no benefit demonstrated when highly heterogeneously functioning survivors are included in studies of a uniform rehabilitation intervention. However, for the future designs of ICU and post-hospital ICU Survivor exercise-rehab trials, the field is in need of information on how to label sepsis patients by their predicted outpatient recovery trajectory group, and to be able to do so very proximally in their course, prior to hospital discharge. The intent of this study is to closely track and characterize physical function recovery trajectory groups as a means of informing strategies for effective future study design.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sepsis requiring organ support in an ICU setting

Exclusion criteria

  • 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

Treatment and study plan

There is no intervention

Other

there is no intervention

Primary outcomes

  1. Short Performance Physical Battery

    Time frame: 3 months post hospital discharge

    Physical function score

Study contacts

Contact information is provided by the study sponsor or research team.

peter morris, md

CONTACT

[email protected]

(205) 934-5555

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • CTSA

Registry information

Official study title

Prediction of Sepsis Recovery Physical Performance Subtypes: A Pilot Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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