Sepsis
Conditions
Keywords
sepsis, critical closing pressure, tissue perfusion pressure, risk stratification
Brief summary
The goal of this observational study is to learn about the roles of critical closing pressure and tissue perfusion pressure in monitoring hemodynamic status, evaluating organ damage, and predicting mortality risk in patients with sepsis. The main question it aims to answer is: • Whether increases in critical closing pressure or tissue perfusion pressure are associated with a reduced risk of poor prognosis? Within the 24 hours following the diagnosis of sepsis, patients will be categorized into four groups based on their 24-hour mean critical closing pressure (Pcc) and tissue perfusion pressure (TPP) estimated from the hourly hemodynamic data within 24 hours. Outcomes will then be compared across these different groups. The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1937 and K25C0792).
Detailed description
To validate the reliability of mean Pcc estimated in the primary analysis, we prospectively collected hemodynamic data over a 24-h period from adult ICU patients with invasive arterial monitoring. Two methods were employed to estimate the mean Pcc for reliability validation. Based on the results of preliminary experiment, the sample size calculation showed that at least 12 individuals were needed for reliability validation.
Interventions
OTHERNo Intervention: Observational Cohort
No intervention.
Sponsors
Fu Xing Hospital, Capital Medical University
West China Hospital
First Hospital of China Medical University
Shanghai Zhongshan Hospital
The First Hospital of Jilin University
China-Japan Friendship Hospital
Beijing Friendship Hospital of Captial Medical University (Beijing)
Beijing Chao Yang Hospital
General Hospital of Ningxia Medical University
Xiangya Hospital of Central South University
Beijing Tongren Hospital
Peking University Third Hospital
Xuanwu Hospital, Beijing
Beijing Tiantan Hospital
Guangdong Provincial People's Hospital
Peking Union Medical College Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Sepsis was diagnosed according to Sepsis 3.0 criteria; * ICU stay exceeding 24 hours after enrollment; * Undergoing continuous monitoring of vital signs.
Exclusion criteria
* Significant absence of blood pressure and heart rate data within 24 hours of enrollment; * Pregnancy or breastfeeding; * brain death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU mortality | From the date of trial enrollment until the date of discharge from ICU or date of death from any cause, whichever came first, assessed up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital mortality | From the date of trial enrollment until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 6 months |
| Incidence of acute kidney injury within 7 days of enrollment | From enrollment to 7 days post-enrollment or death |
| Incidence of acute kidney injury within 48 hours of enrollment | From enrollment to 48 hours post-enrollment or death |
| The maximum vasoactive inotropic score | From enrollment to 24 hours after enrollment or death |
Countries
China
Outcome results
None listed