Predicton of Sepsis Recovery Performance Subtypes Pilot Study

Recruiting

• Conditions: Sepsis

• Registration Number: NCT05912413
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-07-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Performance Physical Battery	3 months post hospital discharge	Physical function score

Trial Locations

Locations (1)

University of Alabama at Birmingham (UAB) Hospital; 🇺🇸 Birmingham, Alabama, United States