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AI could help heart surgery patients get the right Anti-Inflammatory drug

NCT ID NCT07583290

Knowledge-focused Sponsor: Beijing Anzhen Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is looking at whether an artificial intelligence tool can help doctors decide which heart surgery patients might benefit from a drug called ulinastatin. Ulinastatin is used to reduce inflammation after surgery, but it doesn't work for everyone. Researchers will analyze data from 10,000 patients across four heart centers in China to build and test the AI tool. The goal is to personalize treatment and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ulinastatin
What this could lead to
If successful, this could help doctors personalize anti-inflammatory treatment for heart surgery patients, potentially reducing complications.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The AI tool needs further validation before it can be used in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who underwent cardiac surgery with cardiopulmonary bypass at 4 tertiary cardiac centers in China, including coronary artery bypass grafting, valve surgery, congenital heart defect repair, and major vascular surgery. Patients are categorized based on perioperative ulinastatin use (ulinastatin group vs. control group). Data collected from electronic medical records.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients underwent extracorporeal circulation heart surgery, including coronary artery bypass grafting, valve repair or replacement surgery, congenital heart defect repair surgery, and major vascular and aortic disease surgeries; * Patients received standard treatment (such as anticoagulation, circulatory support), with or without ulinastatin. Exclusion Criteria: * Patients who had undergone cardiopulmonary bypass surgery multiple times; * Patients with incomplete clinical records, lacking key information such as patient ID, age, gender and disease diagnosis.

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Conditions

The condition(s) this trial relates to.

aortic disorder congenital heart disease coronary artery disorder heart valve disorder multiple organ dysfunction syndrome Postoperative Complications Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgical procedures Cardiopulmonary bypass Multiple organ dysfunction syndrome Postoperative complications Systemic inflammatory response syndrome

Contacts and locations

Locations

  • Center for Cardiac Surgery and Critical Care

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.