Derivation and Validation of Hemodynamic Phenotypes of Cardiac Surgery

Completed

• Conditions: Phenotyping; Machine Learning; Cardiac Surgery; Hemodynamic Parameters

• Registration Number: NCT07085208
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

Background \& Objective:

Cardiac surgery patients differ significantly in their health conditions and how they react during operations. Standard risk assessments before surgery often miss the real-time changes happening inside a patient's body during the procedure, which can affect their recovery. Therefore, researchers conducted this study to find different groups (phenotypes) of patients who face varying risks for poor outcomes. They did this by using advanced computer learning techniques to analyze a lot of detailed health information collected both before and during surgery.

Methods:

This was a study that looked back at patient records from several hospitals. Researchers gathered a large amount of patient information from before surgery, including their basic health details and lab results. They also collected very detailed measurements of patients' vital signs taken during surgery, noting how these changed over time. Then, a computer program that can find patterns without being told what to look for (unsupervised hierarchical clustering) was used to sort patients into distinct groups based on this combined data.

Clinical Relevance:

This study expects to show that using data to identify patient groups can reveal differences that traditional methods miss. These new patient groups, which are based on how their blood flow and vital signs behave, offer a new way to understand risks in real-time. This could help doctors to predict problems more accurately and create personalized care plans for each patient around the time of surgery, which has great potential for practical use in hospitals.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10847

Inclusion Criteria

• Patients aged 18 years or older
• Patients who underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

• Incomplete information on surgical procedures,
• With History of prior cardiac surgery or underwent second surgery during the same hospitalization
• Insufficient valid perioperative vital sign monitoring data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute organ dysfunction	Within 7 days post-surgery for acute liver failure and acute kidney inkury, and 90 days for postoperative acute kidney disease	including postoparative acute liver failure and acute kidney injury (up to 7 days postoperative), and acute kidney disease(up to 90 days postoperative)

Secondary Outcome Measures

Name	Time	Method
Total LOS and ICU-LOS	up to 90 days post-surgery	Length of hospital stay and length of ICU stay
In-hospital mortality	up to 90 days postoperative, from the end of surgery until patient discharge	All-cause in-hospital mortality