Predicton of Sepsis Recovery Performance Subtypes Pilot Study

Sepsis Clinical Trial

Official title:

Prediction of Sepsis Recovery Physical Performance Subtypes: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912413
• Other study ID #: IRB-300010502-003
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: peter morris, md
• Phone: (205) 934-5555
• Email: pmorris[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• there is no intervention
there is no intervention

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham (UAB) Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Performance Physical Battery	Physical function score	3 months post hospital discharge