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Clinical Trials/NCT05976204
NCT05976204
Completed
Not Applicable

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

National Cardiovascular Center Harapan Kita Hospital Indonesia1 site in 1 country501 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Enrollment
501
Locations
1
Primary Endpoint
Number of Patients Requiring Redo surgery
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Responsible Party
Principal Investigator
Principal Investigator

Sisca Natalia Siagian

Principal Investigator

National Cardiovascular Center Harapan Kita Hospital Indonesia

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

Outcomes

Primary Outcomes

Number of Patients Requiring Redo surgery

Time Frame: 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

Time Frame: Until 30 days postoperative

Mortality intraoperative or postoperative

Complications (categorized as mild, moderate, severe)

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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