Heart surgery study seeks clues to better recovery
NCT ID NCT06080295
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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287 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Sep 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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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.
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