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OpenTrials
Completed

NCT Number: NCT07085208

Derivation and Validation of Hemodynamic Phenotypes of Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

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

Treatment and study plan

Unsupervised Machine Learning for Clinical Phenotyping

Procedure

This is a data-driven study that uses an unsupervised machine learning algorithm to perform clustering on patient multimodal features. These features include: preoperative demographics, comorbidities, and laboratory data; surgical information; and high-resolution intraoperative data, most notably continuous vital sign trajectories.

Primary outcomes

  1. Acute organ dysfunction

    Time frame: 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 outcomes

  1. Total LOS and ICU-LOS

    Time frame: up to 90 days post-surgery

    Length of hospital stay and length of ICU stay

  2. In-hospital mortality

    Time frame: up to 90 days postoperative, from the end of surgery until patient discharge

    All-cause in-hospital mortality

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Derivation and Verification of Hemodynamic Clinical Subphenotypes in Patients Undergoing Cardiac Surgery Under Unsupervised Machine Learning

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2025
Registry last updated
Jul 25, 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.

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