Clinical trial NCT06657196: Pcrit and TPP for Risk Stratification in Patients with Sepsis
Official title: The Roles of Critical Closing Pressure and Tissue Perfusion Pressure in Risk Stratification for Patients with Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
critical closing pressure
tissue perfusion pressure
risk stratification
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Fu Xing Hospital, Capital Medical University
name: West China Hospital
name: First Hospital of China Medical University
name: Shanghai Zhongshan Hospital
name: The First Hospital of Jilin University
name: China-Japan Friendship Hospital
name: Beijing Friendship Hospital of Captial Medical University (Beijing)
name: Beijing Chao Yang Hospital
name: General Hospital of Ningxia Medical University
name: Xiangya Hospital of Central South University
name: Beijing Tongren Hospital
name: Peking University Third Hospital
name: Xuanwu Hospital, Beijing
name: Beijing Tiantan Hospital
name: Guangdong Provincial People&#39;s Hospital
First posted: 2024-10-24
Enrollment: 6769
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult septic patients who were admitted to ICUs and received continuous monitoring of vital signs.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU mortality
timeFrame: 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 outcomes:
measure: In-hospital mortality
timeFrame: 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
measure: Incidence of acute kidney injury within 7 days of enrollment
timeFrame: From enrollment to 7 days post-enrollment or death
measure: Incidence of acute kidney injury within 48 hours of enrollment
timeFrame: From enrollment to 48 hours post-enrollment or death
measure: The maximum vasoactive inotropic score
timeFrame: From enrollment to 24 hours after enrollment or death
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Bin Du
role: STUDY_CHAIR
References:
citation: Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.