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Heart surgery study seeks clues to better recovery

NCT ID NCT06080295

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how certain natural chemicals in the body affect recovery after heart surgery. Researchers followed 287 adults having open-heart surgery to see if these chemicals are linked to problems like confusion after the operation. The goal was to better understand these connections, not to test a new treatment.

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

287 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

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

In this prospective, observational cohort study, consecutive adult patients (aged ≥18 years) scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB)-including open-heart valve repair or replacement-were screened for eligibility between October 2023 and September 2025. During the screening phase, patients who met the predefined exclusion criteria, had incomplete perioperative plasma sampling, or declined to provide informed consent were excluded. Ultimately, a final cohort of 287 eligible patients was enrolled in the study . Based on their intraoperative clinical management, the enrolled patients were categorized into the ulinastatin treatment group (n = 123) and the untreated control group (n = 164).

Ages

18 to 80 years

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 1. Patients were eligible for enrollment if they met all of the following criteria: 2. Adult patients aged 18 years or older. 3. Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB), specifically including open-heart valve repair or replacement. 4. Provided written informed consent from the patient or a legally authorized representative. Exclusion Criteria Patients meeting any of the following criteria were excluded from the study: 1. Neurological and Psychiatric Factors: Preoperative cognitive impairment or preexisting delirium. History of severe psychiatric disorders (e.g., schizophrenia, major depressive disorder) requiring significant psychotropic medication use. Major neurological disorders, including a history of stroke, severe cerebrovascular disease, or severe traumatic brain injury within the past six months. 2. Surgical and Systemic Factors: Scheduled for emergent or salvage cardiac surgery. Severe hepatic or renal dysfunction requiring dialysis. Current systemic infection, sepsis, or a state of severe immunosuppression. Pregnant or lactating women. 3. Pharmacological Factors: Administration of nitrates after hospital admission (due to potential confounding effects on endothelial function and nitric oxide signaling).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

More trials for these conditions

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