Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle: The Acute Development and Persistence of Frailty, Comorbidity and Disability in Critically Ill Patients After Intra-abdominal Sepsis "Induced Frailty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Rockwood Frailty Criteria.
研究概览
简要总结
The purpose of this study is to define the natural history and causes of chronic critical illness (CCI) in surgical intensive care patients who have had sepsis. The investigator wants to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of this research study is to define the acute changes in frailty (weakness, slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and performing routine daily functions) after having an infection that is located in the abdominal cavity or torso. The investigator believes having severe infection contributes to acute and permanent changes in these areas, especially in those of advanced age.
详细描述
This is a prospective study aimed at identifying the frequency, natural history and long term outcomes of CCI and PICS in the survivors of Intra-abdominal sepsis.
In addition to the in-hospital clinical data collected from the parent study, pre and post-sepsis measurements of frailty, comorbidity and disability will be obtained via questionnaires and the electronic health records. Frailty, comorbidity and disability assessments will also be completed at the three, six, and 12 month follow up assessments.
Frailty measures A frailty index will be determined as a combination of factors.
An older adult is considered physically vulnerable when they experience:
- muscle weakness
- fatigue
- low physical activity, and unintentional loss in body weight, which has been agreed upon by a consensus of experts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the surgery or trauma ICU where clinical care can be managed by surgical critical care guided by standard operating procedures.
- •Age ≥18 years
- •Diagnosis of sepsis, severe sepsis, or septic shock
- •Entrance into the standard-of-care sepsis protocol
- •Ability to obtain patient/legally authorized representative informed consent.
排除标准
- •Significant traumatic brain injury (evidence of neurologic injury on CT scan and a best Glascow Coma Scale <8 within 24 hours of injury)
- •Refractory shock (i.e., patients who die within 12 hours)
- •Alternative or confounding diagnosis causing shock state (e.g., myocardial infarction or pulmonary embolus)
- •Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
- •Patients deemed to be futile care or have advanced care directives limiting resuscitative efforts such as patient or patient's family who are not committed to aggressive management of the patient's condition. Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. Recurrent, advanced or metastatic cancer).
- •Severe Congestive Heart Failure (NY Heart Association Class IV)
- •Child-Pugh Class C liver disease or pre-liver transplant.
- •Known HIV infection with CD4 count<200 cells/mm3,
- •Organ transplant recipient on immunosuppressive agents
- •Known pregnancy
- •Inability to obtain informed consent
- •Prisoners
- •Institutionalized patients
- •Chemotherapy or radiotherapy within 30 days prior to sepsis
- •Spinal cord injuries resulting in permanent sensory and/or motor deficits.
研究组 & 干预措施
Intra-abdominal sepsis
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
干预措施: Frailty Measurements (Other)
Intra-abdominal sepsis
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
干预措施: Modified Minnesota Leisure Time Activities (Other)
Intra-abdominal sepsis
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
干预措施: Computed tomography morphometrics (Other)
Intra-abdominal sepsis
Frailty measurements. Modified Minnesota Leisure Time Activities. Computed tomography morphometrics. Mobility Monitors.
干预措施: Mobility Monitors (Other)
结局指标
主要结局
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Rockwood Frailty Criteria.
时间窗: Baseline, 3, 6 and 12 months.
Rockwood Frailty Criteria: Ratio (0-1.0) based on number of positive clinical factors of a 70 item list of clinical deficits (i.e. 7/70 deficits = 0.1). Ratio score, no units of measure.
A change in rate of participants (0-100%) that meet frailty consensus criteria comparing baseline score to assessments after (3, 6, 12 months) episode of intra-abdominal sepsis using the Fried Frailty Criteria.
时间窗: Baseline, 3, 6 and 12 months.
1\. Fried Frailty Criteria: Possible score of 0-5 based on clinical criteria. Score of 0 = "Not Frail", Score of 1-2 = "pre-frail", score ≥3 = "Frail". Integer score, no units of measures
次要结局
- A change in the Modified Minnesota leisure time activities questionnaire from baseline to the one year mark.(Baseline, 3, 6 and 12 month)
- Mortality(Up to one year)
- Change in measurement of torso sarcopenia.(Baseline, 3, 6 and 12 months.)
- A change in mobility and activity from hospitalization to the one year mark.(Baseline, 3, 6 and 12 months.)