NCT06657196

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,769 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	No Intervention: Observational Cohort	No intervention.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2024-10-24
• Last updated: 2025-03-18

Locations

1 site across 1 country: China