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临床试验/NCT05912413
NCT05912413招募中不适用

Prediction of Sepsis Recovery Physical Performance Subtypes: A Pilot Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Short Performance Physical Battery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Sepsis requiring organ support in an ICU setting

排除标准

  • •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
  • •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.

结局指标

主要结局

Short Performance Physical Battery

时间窗: 3 months post hospital discharge

Physical function score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Morris

Professor

University of Alabama at Birmingham

研究点 (2)

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