Predicton of Sepsis Recovery Performance Subtypes Pilot Study

NCT ID: NCT05912413

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-11
• Study Completion Date: 2025-10-15

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.

Detailed Description

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

there is no intervention

there is no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sepsis requiring organ support in an ICU setting

Exclusion Criteria

1. inability to obtain informed consent

2. the attending physician reports that the patient's goals of care are transitioning to palliation/withdrawal of life-sustaining therapy

3. recent cancer therapy in the last 12 months

4. age >80

5. plans to be discharged on mechanical ventilation to a Long Term Acute Care Hospital

6. planned discharge to rehabilitation facility, long-term hospital or nursing home.

7. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Peter Morris

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

peter morris, md

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

peter morris, md

Role: CONTACT

pmorris@uabmc.edu

(205) 934-5555

Facility Contacts

Peter Morris, MD

Role: primary

pmorris@uabmc.edu

(205) 975-6376

Other Identifiers

IRB-300010502-003

Identifier Type: -

Identifier Source: org_study_id