Clinical trial NCT05976204: Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Tetralogy of Fallot
Neutrophil-lymphocyte Ratio
Absolute Lymphocyte Count
Thrombocyte-lymphocyte Ratio
Outcome
TOF
Keywords: Congenital Heart Disease
Tetralogy of Fallot
Neutrophil-lymphocyte ratio
Absolute lymphocyte count
Thrombocyte-lymphocyte ratio
Outcome
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 501
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022

Brief summary: 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.

Detailed description: This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The preoperative demographic data included were patients' gender, age, weight, oxygen saturation, and associated diagnosis other than ToF. The preoperative data of complete blood count and differential count must be tested from the most recent peripheral blood samples taken no later than 14 days before the surgery. The data obtained were the number of days of the most recent blood test including the leukocyte count, percentage neutrophil, percentage and absolute lymphocyte count, thrombocyte count, as well as the derived variables such as neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and followed-up for any complications and postoperative mortality during the same hospital stay until discharge. Patients were then followed up for any cause of mortality within 30 days postoperative.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Requiring Redo surgery
timeFrame: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
measure: Mortality
timeFrame: Until 30 days postoperative
measure: Complications (categorized as mild, moderate, severe)
timeFrame: From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
measure: Postoperative Length of Stay
timeFrame: From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita Jakarta Indonesia
Study officials:
affiliation: National CCHK
name: Sisca N Siagian, MD
role: PRINCIPAL_INVESTIGATOR
References: