Skip to main content
OpenTrials
Completed

NCT Number: NCT06657196

Pcrit and TPP for Risk Stratification in 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention.

Primary outcomes

  1. ICU mortality

    Time frame: 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

  1. In-hospital mortality

    Time frame: 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

  2. Incidence of acute kidney injury within 7 days of enrollment

    Time frame: From enrollment to 7 days post-enrollment or death

  3. Incidence of acute kidney injury within 48 hours of enrollment

    Time frame: From enrollment to 48 hours post-enrollment or death

  4. The maximum vasoactive inotropic score

    Time frame: From enrollment to 24 hours after enrollment or death

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital of Captial Medical University (Beijing)
  • Beijing Tiantan Hospital
  • Beijing Tongren Hospital
  • China-Japan Friendship Hospital
  • First Hospital of China Medical University
  • Fu Xing Hospital, Capital Medical University
  • General Hospital of Ningxia Medical University
  • Guangdong Provincial People's Hospital
  • Peking University Third Hospital
  • Shanghai Zhongshan Hospital
  • The First Hospital of Jilin University
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Xuanwu Hospital, Beijing

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.