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

Dengue Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407181
• Other study ID #: DHFandHFLC
• Status: Recruiting
• Start date: June 3, 2022
• Est. completion date: June 5, 2022

Study information

• Verified date: June 2022
• Source: Universitas Sebelas Maret
• Contact: Nurhasan Agung Prabowo, MD
• Phone: 6282328010430
• Email: dr.Nurhasan21[@]staff.uns.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: June 5, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever

Intervention

Other:
• Blood and Liver Function test
Data was collected through routine blood and liver function tests using a hematology analyzer and ELISA, respectively.

Locations

Country	Name	City	State
Indonesia	RS UNS (Universitas Sebelas Maret Hospital)	Sukoharjo	Central Java
Indonesia	Universitas Sebelas Maret Hospital	Sukoharjo	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Nurhasan Agung Prabowo

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of SGPT/ALT with Lymphocytes	Correlation of SGPT/ALT with Lymphocytes	May 30-June 5 2022
Primary	Correlation of SGPT/ALT with HFLC	Correlation of SGPT/ALT with HFLC	May 30-June 5 2022