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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05641584
Other study ID # 2022/155
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2022
Est. completion date July 10, 2022

Study information

Verified date December 2022
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis.


Description:

Inflammation is causally associated with both coronary artery disease and aortic stenosis. Although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. The role of inflammation in the pathogenesis of AS It will be investigated that mortality may be associated with increased inflammation in patients treated with AVR. Adult patients (aged ≥18 years) with ASA II-IV who underwent elective aortic valve replacement under cardiopulmonary bypass (CPB) due to aortic stenosis in our clinic between January 1, 2010 and March 31, 2022, will be included in the study by retrospectively scanned from the computer system and patient cards. The exclusion criteria from the study are as follows; those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine >2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy. Demographic characteristics of patients (age, gender, body mass index, diabetes mellitus, hypertension, chronic kidney disease-failure, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction, coronary artery disease history, Cabg history) Europe Cardiac Operative Risk Assessment System II (EuroSCORE), Systemic Immune-Inflammatory Index (SII), APACHE II, SOFA Score, NYHA III/IV values, drugs used (ASA, oral anticoagulants, beta blocker, statin, ACE inh., ARB) , preoperative glucose, HbA1c, urea, creatinine, total cholesterol, LDL, HDL, triglyceride, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocytes, monocyte/HDL ratio, CRP, preoperative and postoperative EF and PAB values, ICU admission duration, duration of invasive mechanical ventilation, type of discharge, amount of ES replaced will be recorded. Operation time, cardiopulmonary bypass (extracorporeal circulation) time, cross clamp time, inotropic and vasopressor requirements will be recorded)


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date July 10, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: be over the age of 18, ASA II-IV Patients scheduled for cardiac surgery due to on-pomp aortic valve replacement Exclusion Criteria: emergency operations, off pump)pumpless surgery, revision (repetitive) operations, those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine >2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy, patients where data variables cannot be saved due to technical problems.

Study Design


Intervention

Other:
retrospective data review study
Patient information will be scanned retrospectively from the computer environment and patient cards. No intervention will be made to the patients.

Locations

Country Name City State
Turkey ISTANBUL Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul Bakirköy

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality in patients who underwent aortic valve replacement due to aortic stenosis. 6 month
Primary morbidity The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis. in patients who underwent aortic valve replacement due to aortic stenosis. 6 month
Secondary Inflammation Inflammation is causally associated with both coronary artery disease and aortic stenosis. Although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. The role of inflammation in the pathogenesis of AS It will be investigated that mortality may be associated with increased inflammation in patients treated with AVR. 6 month
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