The Kallikrein-Kinin System in Cardiac Surgery

NCT06080295 | Completed DMC

• 1 other identifier: TJ-IRB20230932
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to established an interlink among the kallikrein-kinin system (KKS), endothelial dysfunction and POD in response to cardiosurgery , using clinic investigation.

Conditions

Cardiosurgery

Keywords

KKS; tissue kallikrein; ;cardiosurgery;cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

• KLK1 level

  KKS related factors levels

  24 hours

• POD-postoperative delirium

  Confusion Assessment Method for the ICU (CAM-ICU)

  7 days

Secondary Outcomes (2)

• survival

  7 days

• Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography.

  24 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• Patients were eligible for enrollment if they met all of the following criteria:
• Adult patients aged 18 years or older.
• Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB), specifically including open-heart valve repair or replacement.
• Provided written informed consent from the patient or a legally authorized representative.

You may not qualify if:

• Patients meeting any of the following criteria were excluded from the study:
• 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.
• 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.
• Pharmacological Factors:
• Administration of nitrates after hospital admission (due to potential confounding effects on endothelial function and nitric oxide signaling).

Sponsors & Collaborators

• Qin Zhang: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Preserving plasma by utilizing blood samples remaining from blood gas analysis during surgical procedures.

Study Officials

• Qin Zhang, phd

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phd

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: September 20, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)