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

Completed

• Conditions: Thrombocyte-lymphocyte Ratio; Outcome; Neutrophil-lymphocyte Ratio; TOF; Tetralogy of Fallot; Congenital Heart Disease; Absolute Lymphocyte Count
• Interventions: Procedure: ToF primary repair

• Registration Number: NCT05976204
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-27
• Status Verified: 2023-08
• Study First Posted: 2023-08-04
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ToF primary repair	ToF primary repair	Patients who underwent ToF primary repair from January 2020 until December 2022

Primary Outcome Measures

Name	Time	Method
Number of Patients Requiring Redo surgery	From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first	Redo surgery was defined as additional or corrective surgery after the initial primary ToF repair within the same hospital admission.
Mortality	Until 30 days postoperative	Mortality intraoperative or postoperative
Complications (categorized as mild, moderate, severe)	From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first	Complication was defined as any adverse events that arised during the operation or postoperative until the discharge of the patient.

Secondary Outcome Measures

Name	Time	Method
Postoperative Length of Stay	From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first	Longer postoperative LOS was defined as hospitalization of more than 5 days from the period of surgery until postoperative discharge (based on our center).
Hospital Length of Stay	From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first	Hospital length of stay (HLOS) was defined as the duration of stay in the hospital from the initial admission to discharge.

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita Jakarta Indonesia; 🇮🇩 Jakarta, Indonesia