Pcrit and TPP for Risk Stratification in Patients with Sepsis

NCT06657196 | Completed DMC

• 1 other identifier: K6349
• Study Type: observational
• Target: 6,769
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis

Keywords

sepsis; critical closing pressure; tissue perfusion pressure; risk stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

No Intervention: Observational Cohort OTHER

No intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Significant absence of blood pressure and heart rate data within 24 hours of enrollment;
• Pregnancy or breastfeeding;
• brain death.

Sponsors & Collaborators

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

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 34605781 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Du

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 24, 2024
• Study Start: March 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the study.
• Access Criteria: Upon proper requirement sent to the primary investigator.

Locations

CN (1)