Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05976204
• Other study ID #: LB.02.01/VII/2023/NLR
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Neutrophil-lymphocyte Ratio
• Outcome
• Tetralogy of Fallot
• TOF

Intervention

Procedure:
• ToF primary repair
ToF primary repair for patients with ToF

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita Jakarta Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

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