Lymphocyte Count and High Fluorescent Count (HFLC) Correlate With Liver Disorder in Dengue Fever Patients

Lymphocyte Count and High Fluorescent Count (HFLC)Correlate With Liver Disorder in Dengue Fever Patients

Liver dysfunction marked by elevated alanine transaminase enzymes is quite common in dengue patients and subsequently affects the disease's severity and healing process. Unfortunately, liver function tests cannot always be done, especially in hospitals with limited facilities. In contrast, routine hematology tests are considered regular and inexpensive tests that can be performed on dengue patients. Therefore, this study aims to determine hematological parameters as markers of elevated liver enzymes in dengue patients.

Study Overview

• Status: Recruiting
• Conditions: Dengue Fever
• Intervention / Treatment: Other: Blood and Liver Function test

Detailed Description

This cross-sectional study involves 11 dengue fever patients, consisting of 9 men and two women, at Sebelas Maret University Hospital (RS UNS), Sukoharjo. The study was conducted in May 2021. Inclusion criteria included patients who were hospitalised at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever. The research was approved by the Regional General Hospital Health Research Ethics Commission (RSUD) by Dr Moewardi Surakarta with the number 938/X/HREC/2021.

Dengue infection is classified according to WHO 2011 criteria, including dengue fever, dengue hemorrhagic fever, and dengue shock syndrome. Dengue fever has criteria in the form of acute fever with two or more other symptoms (headache, retroorbital pain, myalgia, arthralgia, rash, bleeding manifestations); laboratory investigations support dengue fever (platelets 150,000/mm3, leukocytes <5000/mm3, an increase in hematocrit 5-10%), with other confirmed assays (dengue virus isolation; fourfold increase in dengue-specific IgG or IgM serum; antigen or virus detection by immunohistochemistry, immunoassay, and ELISA; genome detection by RT-PCR). Dengue hemorrhagic fever has symptomatic criteria such as dengue fever plus signs and symptoms of plasma leakage (platelets 100,000/mm3, hematocrit increase 20%, pleural effusion, ascites, hypoproteinemia, or hypoalbuminemia). Meanwhile, dengue shock syndrome has symptomatic criteria such as dengue hemorrhagic fever plus symptoms of tachycardia and cold extremities.

Lymphocyte and HFLC examinations were carried out through a haematology analyser's routine blood tests. Meanwhile, liver function tests in aspartate transaminase and alanine transaminase were performed using ELISA. The range of normal cut-off values for each parameter is 11.7-16.2 mg/dL for hemoglobin, 35-45% for hematocrit, 3.9-5.3 x 106/mm3 for erythrocytes, 4.5-11 x 103/mm3 for leukocytes, 150-450 x 103 /mm3 for platelets, 0.8-5 x 103/mm3 for lymphocytes, 1-1.3 for NLR, and 0-1.4 for HFLC.

Data are presented using descriptive statistics and analysed using IBM SPSS (Statistical Package for the Social Sciences) Statistics 25 for Windows 10. Continuous variables are displayed using mean ± SD or median (IQR). Chi-Square tested the relationship between sex data categorical variables. The relationship between continuous variables of haematological parameter data and alanine transaminase status was tested using an unpaired t-test for normally distributed data, a Mann-Whitney test for data that were not normally distributed, and a correlation test in the form of simple logistic regression. The relationship between variables is significant if the p-value <0.05.

• Study Type: Observational
• Enrollment (Anticipated): 11

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Sukoharjo, Central Java, Indonesia, 57161
      • Recruiting
      • RS UNS (Universitas Sebelas Maret Hospital)
      • Contact: Nurhasan Agung Prabowo, MD; Phone Number: +62 823-2801-0430; Email: dr.nurhasan21@staff.uns.ac.id
      • Principal Investigator: Nurhasan Agung Prabowo, MD
      • Principal Investigator: Devina Ravelia Tiffany Subroto, MD
      • Principal Investigator: Ardhia Fefrine Indarta, MD
    • Sukoharjo, Central Java, Indonesia, 57161
      • Recruiting
      • Universitas Sebelas Maret Hospital
      • Contact: Nurhasan Agung Prabowo, MD; Phone Number: +62 823-2801-0430; Email: dr.nurhasan21@staff.uns.ac.id
      • Principal Investigator: Nurhasan Agung Prabowo, MD
      • Principal Investigator: Devina Ravelia Tiffany Subroto, MD
      • Principal Investigator: Ardhia Fefrine Indarta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is a cross-sectional study involving 11 dengue fever patients, consisting of 9 men and 2 women at Sebelas Maret University Hospital (RS UNS), Sukoharjo.

Description

Inclusion Criteria:

• patients who were hospitalized at UNS Hospital with the following criteria: (1) adult patients (19-65 years); (2) diagnosed with dengue hemorrhagic fever according to WHO 2011 criteria; (3) routine blood examination at least once in seven days since the onset of fever; and (4) checked alanine transaminase and aspartate transaminase levels at least once in seven days from the onset of fever.

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of SGPT/ALT with Lymphocytes	Correlation of SGPT/ALT with Lymphocytes	May 30-June 5 2022
Correlation of SGPT/ALT with HFLC	Correlation of SGPT/ALT with HFLC	May 30-June 5 2022

Collaborators and Investigators

• Sponsor: Nurhasan Agung Prabowo

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 3, 2022
• Primary Completion (ANTICIPATED): June 3, 2022
• Study Completion (ANTICIPATED): June 5, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Body Temperature Changes; Hemorrhagic Fevers, Viral; Fever; Dengue
• Other Study ID Numbers: DHFandHFLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No