Congenital Heart Disease Clinical Trial
Official title:
Prognostic Value of Neutrophil-Lymphocyte Ratio (NLR), Absolute Lymphocyte Count (ALC), and Thrombocyte-Lymphocyte Ratio (TLR) in Predicting the Outcomes of Tetralogy of Fallot Primary Repair
Verified date | August 2023 |
Source | National Cardiovascular Center Harapan Kita Hospital Indonesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.
Status | Completed |
Enrollment | 501 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - All patients with ToF and any other associated cardiac anomalies, who underwent ToF primary repair and had a complete blood cell count with differential count available preoperatively Exclusion Criteria: - Surgery other than ToF primary repair - Association with other procedures (except patent ductus arteriosus/PDA ligation, patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries enlargement) - Preoperative hemodynamic instability - Suspected or confirmed infection with prior antibiotic administration during the same hospital admission - Absence of complete blood count with differential count |
Country | Name | City | State |
---|---|---|---|
Indonesia | National Cardiovascular Center Harapan Kita Jakarta Indonesia | Jakarta |
Lead Sponsor | Collaborator |
---|---|
National Cardiovascular Center Harapan Kita Hospital Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Requiring Redo surgery | Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission. | From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first | |
Primary | Mortality | Mortality intraoperative or postoperative | Until 30 days postoperative | |
Primary | Complications (categorized as mild, moderate, severe) | Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient. | From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first | |
Secondary | Hospital Length of Stay | Hospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge. | From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first | |
Secondary | Postoperative Length of Stay | Longer postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center). | From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first |
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