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| Name | Class |
|---|---|
| Fu Xing Hospital, Capital Medical University | OTHER |
| West China Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Shanghai Zhongshan Hospital |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult septic patients who were admitted to ICUs and received continuous monitoring of vital signs.
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| Name | Affiliation | Role |
|---|---|---|
| Bin Du | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34605781 | Result | 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. | |
| 41349003 |
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IPD will be shared upon proper requirement.
After publication of the study.
Upon proper requirement sent to the primary investigator.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| OTHER |
| The First Hospital of Jilin University | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Beijing Friendship Hospital of Captial Medical University (Beijing) | UNKNOWN |
| Beijing Chao Yang Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Beijing Tongren Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Guangdong Provincial People's Hospital | UNKNOWN |
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| 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 |
| Derived |
| Wang JY, Diao ST, Zhu TY, Chen Y, Li S, Peng JM, Dong R, Xu J, Weng L, Du B. Critical Closing and Tissue Perfusion Pressures in Sepsis: Implications for Risk Stratification-A Retrospective Cohort Study. Anesthesiology. 2026 Apr 1;144(4):886-897. doi: 10.1097/ALN.0000000000005881. Epub 2025 Dec 5. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |