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

August 4, 2023 updated by: Sisca Natalia Siagian, National Cardiovascular Center Harapan Kita Hospital Indonesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • National Cardiovascular Center Harapan Kita Jakarta Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ToF primary repair
Patients who underwent ToF primary repair from January 2020 until December 2022
Procedure: ToF primary repair
ToF primary repair for patients with ToF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first
Mortality
Time Frame: Until 30 days postoperative
Mortality intraoperative or postoperative
Until 30 days 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.
From the initial primary ToF until the discharge of the patients or until 2 weeks after the operation, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: 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.
From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first
Postoperative Length of Stay
Time Frame: 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).
From the initial primary ToF until the discharge of the patients or until 12 weeks after the operation, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

  • Principal Investigator: Sisca N Siagian, MD, National CCHK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB.02.01/VII/2023/NLR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At the moment, the investigators have no plan to share the whole participant data. However, if it is needed, the investigators will

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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