Pcrit and TPP for Risk Stratification in Patients with Sepsis

The Roles of Critical Closing Pressure and Tissue Perfusion Pressure in Risk Stratification for Patients with Sepsis

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).

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: No Intervention: Observational Cohort

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.

• Study Type: Observational
• Enrollment (Actual): 6769

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult septic patients who were admitted to ICUs and received continuous monitoring of vital signs.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Xiangya Hospital of Central South University; Beijing Tiantan Hospital; Shanghai Zhongshan Hospital; Peking University Third Hospital; West China Hospital; Xuanwu Hospital, Beijing; Beijing Tongren Hospital; Beijing Chao Yang Hospital; Guangdong Provincial People's Hospital; China-Japan Friendship Hospital; The First Hospital of Jilin University; Fu Xing Hospital, Capital Medical University; First Hospital of China Medical University; General Hospital of Ningxia Medical University; Beijing Friendship Hospital of Captial Medical University (Beijing)
• Investigators: Study Chair: Bin Du, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: sepsis; risk stratification; critical closing pressure; tissue perfusion pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: K6349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared upon proper requirement.
• IPD Sharing Time Frame: After publication of the study.
• IPD Sharing Access Criteria: Upon proper requirement sent to the primary investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No